Supplier Quality Engineer
Omni Inclusive
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.
Vacancy posted 1 day ago
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