Katalyst CRO ยท 1 day ago
Supplier Quality Engineer
Mounds View, MN
Contract
Onsite
Mid, Senior Level
4+ years expKatalyst CRO is seeking a highly skilled and detail-oriented Supplier Quality Engineer to join their team. The role focuses on ensuring that suppliers meet Healthcare's quality standards and regulatory requirements through supplier qualification, PPAP documentation, and process validation.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Qualify suppliers in accordance with company standards
Manage and maintain the Approved Supplier List (ASL) in compliance with Healthcare's purchasing control procedures
Manage and release all PPAP deliverables including Control Plans, MSA, PFMEA, FAI, etc., within the document control system
Support PPAP execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies
Define Receiving Inspection requirements
Validate test methods in alignment with internal Healthcare procedures
Work with cross-functional teams to develop and implement product acceptance sampling strategies
Deploy supplier quality tools such as PFMEA, MSA, control plans for both new and legacy products
Provide technical assistance to suppliers throughout the product/process qualification lifecycle
Ensure delivery of high-quality parts, materials, and services to prevent defects and support Healthcare's commitment to reliability
Collaborate with suppliers to address SCAPA/Client issues in compliance with company standards
Qualification
Required
Bachelor's degree in Engineering or related field
Minimum 4+ years of experience in supplier quality engineering within the medical device industry
Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans
Familiarity with FDA and ISO 13485 standards
Excellent communication and problem-solving skills
Ability to work independently and in cross-functional teams
Preferred
ISO 13485 Certified Talent preferred by client
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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