Katalyst CRO · 9 hours ago
Engineering Supplier Quality Assurance Engineer
Sterling Heights, MI
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a company focused on quality assurance in engineering. They are seeking an Engineering Supplier Quality Assurance Engineer to evaluate supplier capabilities, perform quality oversight, and conduct audits of supplier quality management systems.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Perform Quality System evaluation of supplier's capability and performance, especially as related to their Quality Management Systems (QMS)
Provide Quality Assurance oversight for procurement and acceptance of subcontractor and supplier products and hardware
MR review and processing including application of appropriate quality provisions to MR's, PO's ,SOW's etc. per all contractual terms
Perform Source Inspection onsite at suppliers to review FPI inspection data, witness any testing including Acceptance Testing and perform Source Inspection of product as applicable at subcontractor/supplier facilities
Audit First Piece Inspection (FPI) reports provided by suppliers for accuracy and compliance to the Technical Data Package (TDP). Including - Source Inspections, First Piece Inspections, Acceptance Test Plans (ATP), and Acceptance Test Reports (ATR) review and approval
Support third party evaluation of the suppliers QMS system including ISO 9001:2015, or AS9100D certifications from the supplier if available or conduct a supplier evaluation survey/audit
Maintain an approved supplier list (ASL)
Understand manufacturing processes of fabricated hardware, (e.g. AWS/GDLS welding standards, MIL, SAE, DIN, ANSI, etc. standards)
Support disposition of nonconforming products through the deviation process including Material Review Board responsibilities
Qualification
Required
Must have at least 3 years of experience in the automotive or aerospace industry
Able to review drawings, understanding the application GD&T, Engineering Technical Data Package
Ability to support travel to other GDLS facilities, Government installations and subcontractors 25% of the time
Must have working knowledge of ISO 9001:2015 or AS9100D
Exposure to Oracle Applications, Teamcenter, TIPQA
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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