Senior Quality Engineer
Department: Quality Assurance
Location: Santa Clara, CA
This function will facilitate compliance to applicable internal and external requirements during the entire product life cycle including new product development, device manufacturing/commercialization and post-market, with a primary focus on manufacturing/commercialization. Collaborate with the R&D, Regulatory, Clinical, Marketing and other departments to help facilitate the successful execution of the New Product Development process and launching of robust products. Responsible and accountable for Manufacturing-related Quality Engineering deliverables required within the product development program and with supporting routine manufacturing partnering with Manufacturing Engineering. This position reports to the Director, Quality Engineering and Quality Systems.
Duties & Responsibilities:
- Responsible for the quality aspects for complaint investigations, CAPAs, and nonconformance.
- Supports Manufacturing Engineering in implementing projects to improve yield, reduce costs, or simplify supply chain while ensuring that all product performance requirements are improved or maintained.
- Leads activities to improve manufacturing device adherence to specifications while maintaining or improving product cost.
- Support product development activities: design control, risk management, design reviews, sterilization, biocompatibility and design transfer/process validation.
- Supports product manufacturing activities at contract manufacturers to ensure manufactured product meets product requirements. Supports evaluation of manufacturing and design changes proposed for product improvement or and continuity of supply.
- Responsible for authoring, reviewing and approving test protocols and reports for Design Verification and/or for Process Validation.
- Identify opportunities to proactively assure compliance to all applicable internal, US, and OUS quality regulations including ISO13485 and 21CFR 820 Quality System Regulation.
- Participates in risk management activities including the development, creation and implementation of product process risk analyses, including: Design, Process and User FMEA’s, product biological risk assessments and associated risk documentation per company internal risk management procedures.
- Responsible to feed post-market data from manufacturing, user feedback, and complaints into the risk management program.
- Support failure investigations for product malfunctions encountered during the Design and Development lifecycle and post-market.
- Support supplier qualification and evaluation activities from Quality Engineering perspective.
- Support activities in preparation for internal audit and third-party audits.
- Interprets regulations and requirements and implements programs and procedures to meet these requirements.
- Support for management review and metrics.
- Other tasks as required or assigned by management.
Qualifications (Education, Skills, Training, Experience):
- Minimum undergraduate degree in related field, engineering discipline.
- 5+ years’ experience in Medical Device Industry (Engineering/Quality with Design experience preferred).
- Demonstrated understanding of ISO 13485, ISO 14971, 21 CFR 820.
- Ability to make decisions through careful evaluation of risks and benefits with limited information in conjunction with Director.
- Knowledgeable on device inspection methods, understanding technical documentation including mechanical drawings.
- Professional demeanor towards building relationships and teamwork within team and across functions.
The job responsibilities above are not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
Send your CV/resume to: careers@contegomedical.com
