Supplier Quality Engineer jobs in United States
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Ecocareers ยท 3 days ago

Supplier Quality Engineer

positionMounds View, MN
timeFull-time
remoteOnsite
seniorityMid Level
date4+ years exp

Confidential company is seeking a highly skilled and detail-oriented Supplier Quality Engineer to join their team. This role is critical in ensuring that suppliers meet Healthcare's quality standards and regulatory requirements through supplier qualification, PPAP documentation, and process validation.

Staffing & Recruiting

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 client's commitment to reliability
Collaborate with suppliers to address SCAPA/Client issues in compliance with company standards

Qualification

Supplier Quality EngineeringPPAP DocumentationProcess ValidationISO 13485 CertificationFDA Standards KnowledgeCommunication SkillsProblem-Solving SkillsCross-Functional Collaboration

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

Ecocareers

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Ecocareers provides a specialized job search for careers that make a difference.
location
Bristol, GB
people-size2-10 employees
web-link
https://ecocareers.org

Funding

Current Stage
Early Stage
Company data provided by crunchbase