Senior Supplier Quality Engineer
6 days ago
We are seeking an experienced professional to lead supplier quality assurance, development, and compliance in regulated industries. The role involves ensuring suppliers meet company, industry, and regulatory standards by leading audits, driving quality improvement initiatives, and building strong partnerships.
The ideal candidate will develop and manage supplier quality strategies, policies, and risk management processes. They will lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP). The role also involves conducting supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements.
Key responsibilities include:
- Developing and managing supplier quality strategies, policies, and risk management processes.
- Leading supplier qualification, selection, and approval in alignment with regulatory standards.
- Conducting supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements.
- Oversseeing supplier corrective and preventive actions, root cause analysis, and continuous improvement programs.
Candidates should have a strong background in supplier quality management, auditing, and regulatory compliance. Experience in global supplier management and multicultural environments is highly valued.
Essential Skills and Qualifications
- Proven expertise in supplier quality management, auditing, and regulatory compliance.
- In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, IATF 16949 (if automotive/industrial).
- Proficiency in risk management, root cause analysis, CAPA, Six Sigma, and Lean methodologies.
Requirements
- Bachelor's/Master's degree in Engineering, Life Sciences, or related field.
- 10+ years of experience in supplier quality assurance, preferably in pharma/medical devices/regulated manufacturing industries.
- Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred.
A proven track record in managing global suppliers and delivering measurable quality improvements is essential for this role.
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