Live chat

Sr Supplier Quality Engineer - San Diego, Inc - Irvine, CA

Industry: Medical Devices

Location: Irvine, CA

Zip: 92602

Employment Style: Full Time

Years of Experience: 6-10

Education Level: Bachelor's Degree

Sr Supplier Quality Engineer

Job Description


• Work with suppliers to establish and maintain controlled manufacturing processes utilizing PFMEA.

• Work with suppliers to establish control methods suitable to the nature of the parts they supply.

• Leads teams and manage product focus groups working with suppliers.

• Work with suppliers on measurement methodologies in their receiving inspection area.

• Build relationships with suppliers to ensure all levels of manufacturing understand requirements for injection molding.

• Responsible for supporting Development/Operations Engineering and manufacturing to resolve technical issues and implement corrective and preventive action.

o Particular working on the plastic and metal injection molded commodity

• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams including and Suppliers.

• Responsible for reporting of quality trends and information to management on the performance of plastic suppliers.

• Traveling is approximately 25%-40%.

• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategies for developing new suppliers.

• Work with supplier to establish a structured approach for consistency and adherence to quality procedures and change control requirements.

• Follow up non-conformances during-process inspection, pre-shipment inspection, quality complaints from internal customers, product returns and safety recalls. Identify / drive root cause analysis, corrective action and preventive action implementation.

• Participate in product and process audits as a lead inspector at Plastic molding supplier.

• Work Closely with Supplier Quality team to provide regular updates for Tooling and plastic parts.

• Develop younger Supplier Quality Engineers in the group in the area of Injection molding.


• Bachelor's degree and 8 to 10 years experience is required; or equivalent combination of education and experience. Preferably in Mechanical Engineering or Material Science.

• Experience with managing supplier quality in the production of plastic molding and metal forming processes. Having a familiarity with PCB, PCBA, and electro-mechanical assemblies is a plus.

• Prior experience managing injection molding suppliers or a mold shop

• Prior experience implementing RGJ monitoring systems on molds

• Direct experience with supplier producing parts in a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 20, EN46001, etc.) preferred.

• Must have knowledge of Quality Engineering discipline, including statistics.

• Strong working knowledge of DMAIC Six Sigma problem solving process. Belt certified a big plus.

• Competent in Process Audit, CAPA, PPAP, Equipment Validation.

• Candidate must have high energy and lots of stamina. Must be a team player, and have a strong work ethic.

• Must have good communication skills.

• Candidate must be able to work autonomously and independently.

Client and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

38 days 8 hours ago, Inc


Sr Supplier Quality Engineer - San Diego, Inc - Irvine, CA, United States


Location: Irvine, CA

Company Profile: is the top job search website solution online providing employers with an affordable, easy to use and effective job posting site while offering job seekers a discreet, easy to use service for free. is the best job posting website for savvy employers who want a competitive advantage over other job posting websites. Job seekers who have used other top job boards will appreciate the accuracy and convenience of HireFlyer’s advanced search technology which allows you to receive email or text notifications as soon as an opportunity matching your criteria becomes available. We surveyed, we listened and now we’re bringing the most efficient, accurate and cost effective job posting site to you.