Supplier Quality Engineer

Summary :

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.

Roles & 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. Education & Experience:

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.

bility to work independently and in cross-functional teams.