About the Role
We are seeking an experienced Senior Supplier Quality Engineer to lead supplier qualification, process validation, PPAP activities, and supplier quality improvement initiatives. This role involves working closely with suppliers and cross-functional teams to ensure compliance, process robustness, and the delivery of high-quality products.
Key Responsibilities
- Lead supplier qualification activities and maintain the Approved Supplier List (ASL).
- Drive PPAP execution and supplier process validation using IQ, OQ, and PQ methodologies.
- Review and approve quality documentation including PFMEA, Control Plans, MSA, FAI, and validation records.
- Define receiving inspection requirements and support test method validation activities.
- Collaborate with Engineering, Manufacturing, Procurement, and Quality teams to implement supplier quality strategies.
- Conduct supplier audits and assessments to ensure compliance with quality and regulatory requirements.
- Drive supplier corrective and preventive actions (SCAR/CAPA/NCR) to closure.
- Provide technical guidance to suppliers throughout product and process qualification lifecycles.
- Support continuous improvement initiatives to enhance supplier performance and product quality.
Qualifications
- Bachelor's Degree in Engineering, Science, or a related technical discipline.
- 8–12 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or Quality Systems.
- Strong knowledge of PPAP, APQP, PFMEA, MSA, Control Plans, SPC, and Root Cause Analysis.
- Excellent communication, stakeholder management, and problem-solving skills.
- Experience working with global suppliers and cross-functional teams.
Preferred Qualifications
- Experience in regulated manufacturing industries such as Medical Devices, Aerospace, Defense, or Automotive.
- Knowledge of ISO 13485, FDA Quality System Regulations, and supplier auditing.
- Hands-on experience with Minitab and statistical analysis tools.
- ASQ Certifications (CQE, CSQP, CQA) and/or Lean Six Sigma Green Belt/Black Belt preferred.
