Quality Auditor, Pharmaceuticals
SQA Services, Inc.
Senior Supplier Quality Engineer
Philips
full-time
Posted on:
Location Type: Office
Location: Plymouth • Colorado, Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $89,000 - $131,000 per year
Job Level
Senior
About the role
- Act as Manufacturing Engineer and/product quality at Suppliers to drive problem solving, first time right, DFMAT and process enhancement
- Proactively monitor and measure product/process quality and performance trends and troubleshoot production/release issues
- Act as supplier engineering Single Point of Contact to develop, support, and drive equipment qualification and process validation and verification plans
- Lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations
- Assure quality systems of OEMs, manufacturers and suppliers are maintained and acceptance criteria align with component/product use and customer expectations
- Provide quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation
- Serve as internal and supplier quality auditor; manage planning, execution, reporting and closure of audits and audit findings
Requirements
- 5+ years of experience in Supplier Quality with a manufacturing or product quality focus
- Ability to demonstrate technical innovation and technical leadership
- Mechanical and/or electrical engineering knowledge
- Understanding of and adherence to GMP practices and FDA regulations
- Knowledge and use of relevant PC software applications
- Bachelor’s degree or equivalent of education and experience
- Experienced in DFMAT (Design for manufacturability and testability) and process enhancement at suppliers
- Able to apply DFMEA to review CTS/CTQ for Process Validation and Validation plans at suppliers
- Must be able to perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position
- US work authorization is a precondition of employment; company will not consider candidates who require sponsorship
- Must reside in or within commuting distance to Plymouth MN or Colorado Springs CO; company relocation benefits will not be provided
Benefits
- Philips Total Rewards benefits program
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
- Annual incentive bonus, sales commission or long-term incentives may be offered
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Supplier QualityManufacturing EngineeringProcess ValidationProcess EnhancementDFMATDFMEAMechanical EngineeringElectrical EngineeringQuality AuditingRegulatory Review
Soft skills
Problem SolvingTechnical InnovationTechnical LeadershipContinuous ImprovementCommunicationCollaborationAnalytical ThinkingAttention to DetailProject ManagementInterpersonal Skills
