
Lead Quality Assurance Specialist
2 days ago
The ideal candidate will possess expertise in managing supplier quality assurance, supplier development, and compliance in regulated industries.
- Developing and implementing effective 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.
- Overseeing supplier corrective and preventive actions (CAPA), root cause analysis, and continuous improvement programs.
- Collaborating with cross-functional teams to resolve supplier-related issues.
- Monitoring supplier KPIs and driving improvement initiatives.
- Supporting new product development by ensuring supplier capability for components, raw materials, and services.
- Managing supplier change control processes and evaluating the impact on product quality and regulatory compliance.
- Training, mentoring, and guiding internal teams and suppliers on quality systems and compliance expectations.
The successful candidate will have:
- Strong 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.
- Excellent communication, negotiation, and stakeholder management skills.
- Ability to lead supplier development programs and strategic quality initiatives.
- Experience in global supplier management and multicultural environments.
Qualifications include:
- 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.
- Six Sigma Green/Black Belt certification is a plus.
A proven track record in managing global suppliers and delivering measurable quality improvements is required.
Key Responsibilities:
Assure Supplier Compliance:
- Ensure compliance with quality and regulatory standards through regular audits and assessments.
- Identify and mitigate risks associated with supplier non-compliance.
Develop and Implement Quality Strategies:
- Design and implement effective supplier quality strategies and risk management processes.
- Collaborate with cross-functional teams to drive quality improvement initiatives.
Lead Supplier Development Programs:
- Develop and implement supplier development programs to improve supplier capabilities.
- Collaborate with suppliers to address quality and compliance concerns.
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