- 189088 - QA Design Compliance Engineer
- CA-Southern California - San Diego
- Up to $45.00 DOE
- 4 Months
- Chipton-Ross is seeking a QA Design Compliance Engineer for an opening in Carlsbad, CA.
The Design Compliance Quality Engineer will be responsible for supporting New Product Introduction (NPI) programs by providing input to the development teams and authoring or approving Design Controls deliverables. This Design Assurance position is also responsible for providing guidance and coaching for post market product sustaining activities, such as design changes and CAPAs.
Provide guidance for product development under Design Controls: User and Product requirements, Functional Specifications, Design Verification, Design Validation, Test Method Validation, Risk Management, and Design Reviews.
Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards
Work closely with New Product Introduction teams to meet compliance requirements on schedule
Participate on team projects and assignments, facilitating or leading sub-teams as necessary.
Four (or more) years of progressive professional experience in Design Compliance or Quality Engineering role.
Experience in New Product Introduction and Design Controls.
Experience in molecular biology reagents, instrumentation, and software product development preferred.
Experience in the Lab / IVD / Medical Device field is preferred.
ASQ Certified Quality Engineer (CQE) is a plus.
Strong knowledge of Design Controls, Risk Management, and regulatory guidelines and their application.
Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization.
Ability to act quickly and decisively.
Accredited Bachelor’s degree in a Scientific or Engineering discipline required.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.