Supplier Quality Engineer We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualification, PPAP documentation, and process validation. This role is critical in ensuring that suppliers meet Healthcare's quality standards and regulatory requirements.
Key Responsibilities:
Supplier Qualification & Management: Qualify suppliers in accordance with company standards.
Manage and maintain the Approved Supplier List (ASL) in compliance with Healthcare's purchasing control procedures.
PPAP Documentation & Execution: 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.
Inspection & Test Method Validation: Define Receiving Inspection requirements.
Validate test methods in alignment with internal Healthcare procedures.
Cross-Functional Collaboration: 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.
Technical Support & Quality Assurance: 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.
Issue Resolution: Collaborate with suppliers to address SCAPA/Client issues in compliance with company standards.
Qualifications:
Bachelor's degree in Engineering or related field.
Minimum 4+ years of experience in supplier quality engineering within the medical device industry.
ISO 13485 Certified Talent preferred by client.
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.
