TechDigital Group
Overview
Mandatory : ISO 13485 Certified 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. 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.
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Mandatory : ISO 13485 Certified 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. 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.
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