- 175106 - Quality Engineer - CA
- CA-Bay Area
- Up to $33.83 DOE
- 8 Months
- Chipton-Ross is seeking a Quality Engineer for an opening in Fremont, CA.
Serve as Core team member on New Product Development projects to ensure compliance with Design Controls per ISO 13485 and FDA QSR.
Develop and/or implement quality planning techniques in a medical design/manufacturing environment for new product introductions.
Use statistical and risk management techniques for design and manufacturing and medical device industries.
Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers’ specifications/requirements for products.
Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of Design Transfer.
Advise and evaluate product verification/validation as well as equipment, process and material qualification/validation activities.
Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
Active participation and support of the internal audit process.
Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.
Minimum 3 years of design control related experience in Medical Device / Biologics/ IVD manufacturing.
Experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD, Design Control requirements, and ISO 13485.
Accredited Bachelor's degree
Tyler Harrell at firstname.lastname@example.org
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x342 or (800) 927-9318 x342
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.