How to Apply:

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to recruiter@extendmystaff.com. ExtendMyStaff, Inc. partners with Origen to help hire top talent.  If you are selected to move forward in the process, you will be contacted by an ExtendMyStaff representative.  Unfortunately, due to the volume of candidates, it is not possible to follow-up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

Current Job Openings:

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 5:45am – 2:15pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for: assembly, testing and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Ability to meet production schedules and deadlines according to quality standards
  • Ability to work in a flexible and changing environment
  • Ability to follow detailed written and verbal instructions
  • Ability to learn multiple tasks and train in other areas as needed
  • Ability to work with a variety of tools and equipment
  • Ability to maintain all logs, paperwork and forms accurately
  • Required to understand, access and make entries to documents on the company Electronic Document System
  • Ability to accurately perform job duties with minimum supervision
  • Ability to adhere to cleanroom dress code and policies
  • Ability to work in a multi-cultural team environment and be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Punctual and Reliable!!

Required Skill Sets

  • Must be detailed oriented and be able to focus on a repetitive task for long periods of time
  • Must be proficient on computer, possessing basic navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment  

Preferred Qualifications

  • Prior Clean Room experience preferred

Compensation

Based on experience and ability

Manufacturing Engineer

Position Summary

The Manufacturing Engineer will evaluate and develop processes to ensure quality, cost and efficiency requirements are met. He/She will troubleshoot problems with production and take corrective actions and will research and make recommendations on the purchase of equipment and/or upgrades to existing equipment.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Design, evaluate, implement and monitor processes and operating systems for the manufacture of medical devices.
  • Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
  • Support the conversion of small-scale processes into commercially viable large-scale operations.
  • Assume responsibility for safety/environmental issues and ongoing performance of processes.
  • Stay up-to-date and follow all Quality System procedures related to this job which can affect the quality of products or services provided to our customers.
  • Select, develop, validate, setup and maintain manufacturing processes, equipment, and tooling.
  • Support production through efficient and effective identification and resolution of line issues.
  • Identify, initiate, and execute process, cost reduction and process improvement projects.
  • Properly document activities in accordance with best engineering practices, company procedures and cGMP, FDA, and ISO 13485 regulatory requirements.  Follow good project management practices.
  • Interface with external vendors to source equipment and fixtures.
  • Effectively train operators, technicians, and engineers on use of equipment and fixtures.
  • Participate and drive continuous improvement projects related to manufacturing.
  • Participate in product development teams to provide input from a manufacturing perspective.
  • Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
  • Knowledgeable in medical device GMP processes in a FDA regulated industry.
  • Provides manufacturing engineering information by answering questions and requests.
  • Design production tooling as required.
  • Experience procedure writing with ability to create, update, implement and improve procedures.
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures; requesting special service.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
  • Contributes to team effort by accomplishing related results as needed.
  • Central contact for Facility and Equipment Maintenance.
  • Other duties and/or projects as assigned.

Competencies

  • Dealing with Complexity/Ambiguity
  • Informing Others/Communication
  • Curious/Creative
  • Leadership
  • Adaptability
  • Results-driven
  • Technical Capacity
  • Ethical Conduct
  • Communication
  • Decision making
  • Interpersonal skills
  • Self-Awareness/EQ
  • Stress Management

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Engineering and/or equivalent, directly relevant/compatible job experience
  • 4 years’ experience in a small medical device manufacturing environment
  • Experience implementing Demand Flow Technology (DFT) processes
  • Experience in creating Value Stream Mapping (VSM)
  • Experience implementing LEAN manufacturing processes; 6 Sigma Green or Black Belt
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshoot ability
  • Strong ability to understand and interpret customer needs; customer-centric; ability to proactively work with diverse work teams (i.e. Sales, Operations, Human Resources, Quality)
  • Strong interpersonal and people skills
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Strong and effective communication skills (verbal and written) with ability to communicate cross-functionally and up/down chain
  • Pays very close attention to detail
  • Self-motivated, hands-on with keen interest in quickly learning and applying new skills/concepts
  • Ability to follow written/verbal instructions and meet deadlines with minimal supervision
  • Ability to react quickly to changing requirements and new processing developments
  • Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel.

Preferred Qualifications

  • Knowledge of Hardware Specifications, Manufacturing Methods and Procedures
  • Progressive experience related to Manufacturing Quality, Product Development, Presenting Technical Information, IQ/OQ/PQ techniques
  • Working/demonstrable knowledge of automation and implementation experience strongly preferred
  • Experience with SolidWorks and Epicor a plus

Supervisory Responsibility
This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job may operate in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience

QA Specialist I/II

Position Summary

The QA (Quality Assurance) Specialist I/II develops programs to support and implement the Quality Management System as developed for OriGen products and processes.  This includes creation of documents and reports on both product quality as well as the effectiveness of the Quality system. Working with the QA Manager (and/or RA/QA Director), they will create a system of continuous improvement for both products and quality reporting.  

Essential Functions

Quality activities include:

  • Write, revise, and approve documents and reports related to quality system activities.
  • Works to increase outgoing product quality
  • Works with suppliers to maintain and improve incoming material quality
  • Works with QA staff to maintain and increase competency and efficiency
  • Manage the Electronic QMS, and train others in its use
  • Assist with document control activities
  • Assist with risk assessment/ risk analysis
  • Performs corrective/preventive action planning and execution
  • Performs complaint investigation and trending
  • Conducts and supervises Internal Audits
  • Prepares for and participates in inspections/audits by external auditing organizations and customers
  • Assists with field actions including FSCAs and recalls
  • Assists in development of Management Review content

Competencies

  • Thorough knowledge of 21 CFR 820, ISO 13485:2016 and MDSAP requirements
  • Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques
  • Familiar with using an eQMS system
  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Interpersonal skills necessary to work effectively in a team environment.
  • Works cross functionally to complete projects and testing.
  • Exercises judgment within broadly defined practices and policies.
  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization

Required Education and Experience

  • Bachelor’s Degree or equivalent in life science or engineering field
  • Minimum of 3 years’ experience in medical device quality assurance discipline: knowledge of domestic and international medical device quality system regulations and standards

Preferred Education and Experience

  • Certified Internal Auditor (ASQ or similar program)
  • Experience in ERP and eQMS/eDMS systems

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m.  In some cases, additional work hours may be required.

Travel

5%

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
  • This job periodically operates in a cleanroom environment.  Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Commensurate with Experience.

QA Technician, Inspector

The QA Technician, Inspector works with limited supervision to conduct incoming, in-process, and final product inspection; support the control and disposition of nonconforming materials and supplier corrective actions; calibrate equipment; create, finalize and maintain quality records; process customer returns; and print product labels.

Essential Functions:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Performs inspections of incoming, in-process, and final product for conformance to quality assurance standards using an approved sampling plan.
  • Accurately completes all quality control documentation and inspection sheets in accordance with ISO 13485 Standard and established procedures.
  • Verify inspection equipment, machinery and tools used are calibrated per company policy.
  • Follows verbal and/or written instructions such as production traveler, work instruction, process specifications, and drawings at the direction of supervisor in completing a variety of inspection tasks.
  • Makes decisions as to the acceptable quality; determines reasons for rejection; completes required quality records.
  • Identify, initiate quarantine, report and document all nonconforming product.
  • Bring problems/issues to attention of Management.
  • Work efficiently to achieve targeted goals as set by the production schedule.
  • Participates and/or assists with cross training activities, training of new hires and temporary staff. Follows set training program for position and ensures training requirements are up to date.
  • Demonstrates safe work habits, maintain clean and safe work area.
  • Performs other duties as assigned, to maintain efficiency throughout the company.
  • Conducts equipment calibration activities, requiring a good understanding of current metrology practices and use of measuring instruments.

Competencies

  • General understanding of ISO 13485:2003 and FDA 21CFR Part 820: Quality System Regulation.
  • Proven skills in performing product dimensional inspections, including understanding of geometric dimensions and tolerances.
  • Demonstrated understanding of the selection and use of sampling plans.
  • General understanding of root cause analysis and corrective action planning.
  • Works cross functionally to complete projects and testing.
  • Exercises judgment within essential functions
  • Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel
  • Outstanding communication skills, both written and oral, and will be expected to communicate directly with peers, client auditors, senior management and regulatory inspectors.

Work Environment

This job operates routinely in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

 

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 6:00 a.m. to 2:30 p.m. however, shift changes may be required based on business demands. In some cases, additional work hours may be required.

Required Education and Experience

  • High school diploma
  • 1+ years as a team lead or supervisor
  • 1 – 3+ years’ experience working within a formalized FDA or ISO Quality System.
  • 1 – 3+ years’ experience within a medical device manufacturing environment.

Preferred Education and Experience

Associates Degree, professional certificate, or equivalent in related field.

Salary:

Commensurate with Experience.

Quality Systems Manager

Position Summary

The Quality Systems Manager is responsible for overseeing the quality management system for OriGen Biomedical, including ensuring compliance to global quality system regulations and standards including 21 CFR 820, ISO 13485:2016 and MDSAP. This position oversees quality system specialists and related staff and manages the daily activities associated with maintaining a compliant quality management system.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Leads a team of quality system personnel, acting as a mentor and facilitating effective communication and workload/priority management
  • Ensure effectiveness of the quality management system, including planning, managing and executing quality policies, procedures, and programs
  • Ensure compliance of the quality management system with global regulations and standards
  • Provides advice and knowledge in regard to interpreting cGMP/QSR guidelines and regulations.
  • Identify and guide areas of QMS improvement and enhancement to meet both the needs of the organization and any new or changing regulatory requirements
  • Coordinate internal and external quality system audits, including those from regulatory authorities, notified bodies, and customers
  • Manage the complaint and CAPA processes, including efficient resolution of complaints and implementation of appropriate corrective and preventive actions to correct or prevent deficiencies
  • Manage document and change control procedures, as well as the training program to ensure all employees maintain training to pertinent procedures
  • Proactively looks for opportunities to identify change, increase efficiency, influence decisions and deliver results while ensuring compliance.
  • Develops, modifies, and drives towards meeting quality metrics that successfully measure the output and adequacy of the quality system
  • Facilitates and leads Management Review along with RA/QA Associate Director
  • Reports progress, issues, challenges, and opportunities to the Associate Director of RA/QA, gathering input, feedback and support as needed to achieve quality goals

Supervisory Responsibility

  • Supervises, mentors and leads quality system staff
  • Maintains training of current quality system staff
  • Recruits and trains new quality system personnel
  • Works closely with other supervisory personnel

COMPETENCIES

  • Proven leadership, including ability to motivate, teach, build up a team and be a member of the team
  • Demonstrated interpersonal skills, including ability to work cross-functionally to achieve business goals
  • Effective communication skills (verbal and written)
  • Sound critical thinking and independent decision making
  • Adaptability/ flexibility
  • Strong organization and time management skills
  • Proactive and self-starter

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

  • Bachelor’s degree in Science, or equivalent
  • 8 years professional work experience Quality Assurance
  • 2 years direct supervisory/ leadership experience
  • Quality Systems knowledge in a regulated environment, including subject matter expert knowledge in 21 CFR 820, ISO 13485:2016, and MDSAP

PREFERRED QUALIFICATIONS

  • Master’s degree in science, or equivalent
  • Quality certification (ASQ, etc.)
  • Certified internal or external auditor
  • Experience working in a manufacturing environment with ISO-qualified cleanrooms

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m.  In some cases, additional work hours may be required.

Travel

5%

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
  • This job periodically operates in a cleanroom environment.  Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Commensurate with Experience.