Current Job Openings:

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 6:00am – 2:30pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:00pm – 12:30am). 

Our company is looking for full-time production personnel to work in a clean room environment for:

Overall job description: 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. 

Job requirements:

  • 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 task and train in other areas as needed
  • Ability to work with a variety of tools and equipment
  • Must be detailed oriented and be able to focus on a repetitive task for long periods of time
  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required
  • 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 as well as be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Ability to read, write, speak and understand English
  • 20/20 Corrective Vision Required
  • Punctual and Reliable!!

Compensation
Based on experience and ability
Past experience working in a GMP environment is definitely a plus, but not required 
And other duties as assigned by the team leads or supervisor

For more information or to apply, please email Morning Shift for the morning shift or  Evening Shift for the evening shift.  Resumes can also be sent via fax or mail, or applications filled out at our office.

Director of QA and RA

Position Summary

The Director of QA and RA is responsible for the operations of the entire Quality and Regulatory organization at OriGen Biomedical

Essential Duties and Responsibilities

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

  • Maintain compliance with applicable US and European medical device regulations

  • Advocate for and work within a medium size device firm

  • Provide clear and concise reporting on QA and RA perspectives

  • Technical writing, direction and submission of Regulatory documentation

  • Manage and improve the Quality function through direct report supervisors, including

    • All internal and external audits

    • CAPA system

    • Supplier assessment

    • Training programs

    • Design control

    • Complaint handling and reporting

  • Participates in all phases of Product Design

  • Collaborates with other departments to integrate Quality processes

  • Participates in Strategic Planning

  • Assists our Distributors in meeting local regulatory requirements

Core Competencies

  • Proven Leadership skills

  • Thorough knowledge of 13485, MDSAP and MDR regulations

  • Knowledge of overall QA functions

  • Ethical Conduct

  • Excellent Interpersonal skills

  • Sound Decision making

  • Good Communication

  • Attention to detail

  • Efficient use of Resources/ Cost reduction

  • Adaptability

  • Innovation



Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Sciences, Engineering, or other closely related field

  • 10 years’ experience in Medical device QA / RA

  • 5 years successful Leadership experience

  • Experience with FDA and Notified Body Inspections

Preferred Qualifications

  • Master’s degree in Sciences, Engineering, Business or other closely related field

  • Professional Certifications in Quality Sciences (Auditing, etc)

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.

Some travel may be required.

Salary:

Commensurate with Experience
 

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

Engineering Group Manager

Position Summary 

The Engineering Group Manager is responsible for management and direction of the Engineering group. This person will provide strategic and tactical direction for the concept and design development of new medical devices as well as on-market support of existing devices. They will help coordinate staffing; develop scheduling and budgetary requirements for the engineering team. They will ensure that the Engineering team helps maintain compliance to medical device regulations and conformance to standards.

 

Essential Duties and Responsibilities

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

  • Direct the Engineering team across multiple projects, pilot production, and engineering services, and motivate the team to successful attainment of departmental and business objectives. 

  • Direct project reviews and pre-production quality assurance process to ensure high quality products are developed with adequate controls and without excess bureaucracy

  • Provide clear technical goals that stretch the organization to deliver innovative products on time while minimizing development effort.

  • Manage existing process validation and improvement to meet ISO and FDA guidelines.

  • Evaluate and prioritize new product development from conception to transfer to manufacturing.

  • Support marketing and customer service on new and existing products.

  • Draft and review Design History Files and Technical Manuals for new and existing products.

  • Represent engineering during routine quality systems meetings (CAPA, Material Review Board, Complaints, and Deviations) and establish priorities for engineering group accordingly.

  • Evaluate and review design, process, and user risk analysis per ISO 14971.

  • Oversee Root Cause Analysis on problems originating from many sources, from production to end-use.

  • Report findings of complaint investigations to customer service and participate in any follow up required directly with customer.

  • Support the Regulatory group with verification and validation activities, maintenance of Design History File documentation, and technical support on new filings.

  • Creates and reviews product and/or system documentation

  • Other duties and/or projects as assigned

Supervisory Responsibilities

This position will lead a group of four to six degreed engineers

 

 

Competencies

  • Leadership

  • Financial Management

  • Broad creativity and curiosity

  • Problem-solving skills

  • Regulatory tech file writing for medical devices

  • Product development experience

  • Project Management

  • Ethical Conduct

  • Communication and interpersonal skills

  • Strategic Thought

  • Adaptability

  • DOE and Validation testing

  • Decision making

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Engineering

  • 7+ years’ experience in medical devices / ISO 13485 environment, including documentation and design control

  • 2+ years in management of a technical team, medical devices experience preferred

  • 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 groups (i.e. Regulatory, Operations, Human Resources, Quality)

  • A working knowledge of material selection and component manufacturing processes – molding, machining, 3D printing

  • Strong interpersonal and people skills

  • Hands-on manufacturing equipment setup, calibration and production training

  • Strong organization and time management skills with the demonstrated ability to meet deadlines

  • Strong and effective communication skills (verbal and written)

  • Close attention to detail

  • Ability to work independently and lead or participate in a team environment

 

Preferred Qualifications

  • MBA or Management degree

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 office environment is usually minimal.

Salary:

Commensurate with Experience
 

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

QA Manager

Position Summary

The QA Manager is responsible for running the entire QA operation at OriGen Biomedical

Essential Duties and Responsibilities

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

  • Direct all daily activities of the QA department

  • Manage and train personnel in all Quality functions including

    • Monitoring and improving all processes that affect product quality

    • Product Inspection

    • Non-Conforming materials

    • Vendor qualification

    • CAPA Investigations and monitoring

    • Complaint processing

    • Internal audits and scheduling

    • Process and Site validations

  • Present weekly Quality Report to Management

  • Keep processes and procedures aligned with current standards

  • Manage external audits and close findings

  • Document progress towards current objectives

  • Working in a small company, juggling many roles

Supervisory Responsibility

  • Supervises department (six and growing)

  • Develops and optimizes department schedules

  • Maintains training of current QA staff

  • Recruits and trains new QA personnel

  • Works closely with other Supervisory personnel

Competencies

  • Broad Quality systems knowledge

  • Proven Leadership

  • Demonstrated Interpersonal skills

  • Effective communication skills (verbal and written)

  • Sound Decision making

  • Adaptability/ Flexibility

  • Teachable

  • Team building, motivation

  • Ethical Conduct

  • Strong computer skills

  • Innovation

Minimum Qualifications (Knowledge, Skills, and Abilities)

 

  • Bachelor’s degree in Science, or equivalent

  • 6 years professional work experience Quality Assurance

  • 4 Years departmental leadership experience

  • Sound problem solving and critical thinking skills; strong troubleshoot ability

  • Confident interpersonal skills

  • Strong organization and time management skills

  • Attention to detail

  • Self-starter

  • Teamwork skills as member and leader

Preferred Qualifications

  • Quality Assurance work in Medical Devices

  • ISO 13485 experience

  • Experience in sterile fill operations

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by any 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
 

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

Process Engineer

Summary

Validate existing and develop new manufacturing processes to ensure quality, cost, and efficiency requirements are met in the manufacture of medical devices. Troubleshoot problems with production and take corrective action. Research the purchase of new equipment and updates to existing equipment.

Essential Functions

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

Engineering activities include:

  • Draft and oversee execution of protocols to validate existing manufacturing processes.
  • Work with product development to plan, implement, and validate processes for new product development and product variants.
  • Research, propose, purchase, and perform IQ/OQ/PQ on new equipment.
  • Establish monitoring program for essential processes to maintain validation, mitigate risk, and improve efficiency.
  • Evaluate and document process risks and tie into validation.
  • Write new and revise existing Standard Operating Procedures based on outcomes of process validation.
  • Investigate and report on customer complaints related to process issues.
  • Identify existing bottlenecks in production and suggest improvements to improve workflow and efficiency.
  • Support production through effective identification and resolution of line issues.
  • Perform Root Cause Analysis of process related problems, plan and implement corrective actions.

Competencies

  • Knowledge of FDA regulations and guidelines for medical device process validation.
  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Proficiency in technical and layman writing.
  • Works cross functionally to complete projects and testing.
  • 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 production management, production technicians, engineers, and senior management.

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 often 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.

 

Salary:

Commensurate with Experience

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail. Click here  for our contact information.