Senior Quality Engineer
2159 India Street
San Diego, CA 92101
Senior Quality Engineer
General Job Description
Mainstay Medical is seeking a driven and passionate Senior Design Quality/Design Assurance Engineer. This individual will actively participate in product development teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled. Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device. We hope you will join us on this journey to ReActiv8 life.
Good understanding of medical device regulation (FDA, EU and international), quality systems requirements (FDA and ISO 13485)
Familiarity with IS0 14971 and product stands such as IEC60601, 10993, and other medical device standards.
Ability to work independently and with all levels of managers, associates, and teams
Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device.
Generates and/or reviews related project deliverables such as: design verification and design validation protocol and reports as well as process validation protocols and reports. Coordinates with Production development in the review of technical documentation.
Works with Product Development/Manufacturing in the development of test fixtures, develop production acceptance criteria and test methodology.
Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination.
Provides support in conducting root cause analyses, preparation of CAPA and Product Risk Assessment. Draft and update SOPs as required.
Support audits and continuous improvement activities
Complete all other related duties assigned.
B.S. degree in Engineering or related fields
3+ years’ experience in Design Assurance, including Quality systems, standards, metrics, and tools. Advanced degrees will substitute for 1 year of experience.
Certified Quality Engineer (CQE)
Excellent verbal communication and interpersonal skills.
Demonstrated excellent organizational skills with attention to detail.
Proficient in computer operations, including Microsoft Word, Outlook, Excel PowerPoint, and basic database management.
Problem solver and capable to find solutions to challenges.
Application Information & Contact (How to Apply)
Forward your resume to: firstname.lastname@example.org
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