Senior Quality Engineer
Posted on Apr 17, 2019 by TE Connectivity
TE's Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world's leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.
The senior quality engineer will join a team of 4 in the process of qualifying NPI and legacy products at TE Connectivity's Medical Device site in Campbell, CA.
- Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).
- Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
- Develop and maintain the pFMEA process for manufacturing.
- Support/participate in regulatory agency and customer quality audits.
- Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.
- Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues.
- Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
- Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
- Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.
- Min. 7 years' experience as a quality engineer in Medical Device manufacturing/OEM/contract manufacturer
- Bachelor's degree in technical field
- pFMEA process experience
- Gage R&R and other validation method experience
- MDR experience
- Strong ISO 13485, 210 CFR 820, and FDA knowledge
- Environmental monitoring experience
What TE Connectivity Offers
We offer a competitive "total rewards" compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive, and meets the needs of our employees.
- Generous 401(k) Plan
- 100% Tuition Reimbursement
- Benefits start on day one
- Charity Donation Matching Program
- Competitive Paid Time Off
- Employee Resource Groups
- Employee Stock Purchase Program
- Healthcare for Associates and Families
- Health and Wellness Incentives
- Life Insurance and Disability Protection
Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.