Supplier Quality Engineer

Senior Supplier Quality Engineer responsible for supplier part qualification, inspection method development, test method validation, and compliance with medical device quality system requirements.

Job Requirements

• Bachelor’s degree with 4+ years of relevant experience, or advanced degree with 2+ years of relevant experience.

• Experience with PPAP part qualification.

• Experience developing and reviewing control plans.

• Experience with PFMEA.

• Experience with IQ, OQ, and PQ documentation.

• Experience conducting process capability studies.

• Experience with First Article Inspections.

• Experience developing inspection methods with suppliers and incoming inspection or metrology teams.

• Experience validating test and inspection methods.

• Experience establishing acceptance sampling plans.

• Experience working within medical device quality system requirements.

Preferred Skills

• Experience with medical device supplier quality engineering.

• Experience with established medical device quality systems and procedures.

• Experience supporting supplier qualification and incoming inspection activities.

• Experience with metrology and dimensional inspection processes.

Job Responsibilities

• Lead PPAP activities for supplier part qualification.

• Develop and review control plans, PFMEAs, qualification documents, process capability studies, and First Article Inspection documentation.

• Coordinate with suppliers and incoming inspection teams to establish part acceptance requirements.

• Develop inspection methods for incoming components and materials.

• Validate inspection and test methods used for supplier parts.

• Establish and maintain acceptance sampling plans.

• Review supplier manufacturing and quality documentation for compliance with applicable requirements.

• Support supplier qualification and ongoing supplier quality activities.

• Investigate supplier-related quality issues and support corrective actions.

• Maintain supplier quality activities in accordance with applicable medical device quality system requirements.

Pay Details: $50.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

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