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). 

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.

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

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

Production Trainer - 2nd Shift

OriGen Biomedical is seeking for a second shift production trainer for our production cleanroom team.  Second shift hours: Monday – Thursday, 2:15pm to 12:45 am

Position Summary

This employee works as part of the production team at OriGen Biomedical. The position provides manufacturing support and training to ensure continuous compliance with training to cGMP requirements and standards.

Essential Duties and Responsibilities

The production trainer would be responsible for administering training to the production teammates. This position assures that Standardized Work is in place and all teammates are following standards.

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

  • Conduct departmental new hire orientation and onboarding

  • Monitor & administer teammate training to support maximum quality and productivity

  • Effectively administer, monitor and report on training initiatives and results

  • Effectively train others in a production/OTJ or classroom environment

  • Conduct training audits to identify training gaps

  • Conduct on the job training to correct deficiencies and retrain

  • Work and communicate cross functionally to complete projects and training

  • Provide regular, ongoing feedback to teammates regarding progress

  • Evaluate and assess team member capabilities and provide metrics/data to Production leadership

  • Other duties and/or projects as needed or assigned

Skillset and Required Experience

  • Strong/functional knowledge of CGMP guidelines and regulations

  • Ability to learn and understand a wide variety of job duties to a high degree of detail

  • Proven track record of distilling and communicating knowledge to others in ways that engage, motivate and foster learning

  • Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel

  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives.

  • Outstanding communication skills, both written and oral

  • Ability to effectively communicate with production supervisors, quality and production personnel.

Competencies

  • Adaptability

  • Attention to Detail

  • Building Relationships

  • Conflict Resolution

  • Communication

  • Developing People

  • Listening

  • Introducing Change

  • Motivating Others

  • Personal Effectiveness

  • Presentations

  • Problem Solving/Resolution

  • Results-Driven

  • Sound Judgement

  • Stress Management

  • Teamwork

  • Time Management/Organization

Minimum Qualifications

  • High School Diploma

  • 3 – 5 years progressive production environment experience

  • Demonstrated ability to use critical thinking skills

  • Ability to work independently and within a team environment on assigned projects from inception to completion

Preferred Qualifications

  • Additional advanced certifications a plus

  • 2+ years developing/delivering training in a production environment

  • Cleanroom experience in biomedical industry 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 and in a cleanroom environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. 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 50 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.

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.

RA Specialist I/II

Position Summary

The RA (Regulatory Affairs) Specialist I/II develops documentation to support the Regulatory objectives for OriGen products.  This staff member works to maintain continuous compliance with domestic and international regulatory requirements and standards.  Working closely with the RA Director, they develop and submit regulatory filings and submissions for authorization to market products in US, EU,  Canada, and other international markets as necessary.

Essential Functions

Regulatory activities include:

  • Executing regulatory strategy by preparing submissions for product approval, responding to requests from reviewers, and resolving deficiencies in submissions.
  • Prepare documentation to support international registration dossiers and maintain product registration files and electronic databases.
  • Monitoring standards for changes in regulatory requirements.
  • Act as regulatory representative on product development teams, providing regulatory input to the engineering/project manager
  • Helps maintain Design History Files (DHF), design dossiers, and technical files following product approval.
  • Working with outside auditors to demonstrate regulatory compliance
  • Support medical device reporting and recall management
  • Working with business partners to investigate regulatory pathways/ develop regulatory strategy for new products and/or changes to existing products.
  • Perform regulatory assessment on product or process changes and execute necessary actions such as new 510ks, letters to file, technical file updates, license amendments, etc.
  • Assists in development of Management Review content

Competencies

  • Proven skills in preparing regulatory submissions in the US and Europe (510(k), de Novo and Technical Files).  Experience with international regulatory submissions is a plus.
  • Knowledge of FDA regulations and guidelines, including 21 CFR 820.
  • Knowledge of MDR requirements
  • Knowledge of ISO 13485: 2016 and MDSAP.
  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Interpersonal skills necessary for  working 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 3years’ experience in medical device regulatory affairs discipline: knowledge of domestic and international medical device regulation, practical experience in global registrations and filings (i.e. US, EU, Canada.)

Preferred Education and Experience

  • Completion of RAPS Regulatory Affairs Certification program.
  • RAC certification by examination desired.

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 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.

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%

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

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.