Main responsibilities:

· Act as quality assurance support for the design and development of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan.

· Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues.

· Support multiple projects, balancing priorities, and resources to meet project and management expectations.

· Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

· Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

· Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.

· Perform failure mode analysis on new or existing products. Ensure all reasonable failure modes are identified. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.

· Coordinates for both new products/processes and changes to existing products/processes develop verification and validation plans

Qualifications:

· BS/BA degree in Engineering or field of science such as Chemistry, Microbiology, Biology, Biochemistry)

· 2-5 years’ experience in a quality role within a highly regulated industry

· Hands-on risk management experience in developing and maintaining risk management files such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc.

· 2 years of quality engineering experience (design controls/change control, process validation, on market engineering support and risk management) in a regulated environment.

· Experience reviewing and approving plans and reports for design verification, design validation, and process validations required.

· Experience reviewing and approving Device Master Record (DMR) documents required.

· Knowledge of Quality System Regulations.

· Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.

· Must be detail-orientated, self-motivated and available for flexible scheduling.

Preferred Qualifications:

· Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.

· Experience acting as quality lead supporting new product development desired.

· Experience with design transfer of products from development to production desired.

· Hands on Design Verification, Design Validation, and Design History File (DHF) experience desired.

· Experience with chemistry related reagent, ELISA, HEIA manufacturing desired.

Collaborative Technologies is proud to be an Equal Opportunity Employer.

Job Types: Full-time, Contract

Pay: $50.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Night shift

Ability to commute/relocate:

• Pomona, CA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 2 years (Preferred)
• Quality: 2 years (Preferred)

Work Location: One location

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