Quality Assurance Director
4 days ago
Job Title: Senior Supplier Quality Professional
Location: Bengaluru, Karnataka, India
Employment Type: Part-time
Job Summary:
We are seeking a seasoned supplier quality assurance expert to lead audits, drive quality improvement initiatives and build strong supplier partnerships.
Job Responsibilities:
- Develop and implement strategic supplier quality plans and risk management processes.
- Lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP).
- Conduct thorough supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements.
- Oversee corrective and preventive actions (CAPA), root cause analysis, and continuous improvement programs.
- Collaborate with cross-functional teams to resolve supplier-related issues.
- Monitor supplier key performance indicators (KPIs) and drive improvement initiatives.
- Support new product development by ensuring supplier capability for components, raw materials, and services.
- Manage change control processes and evaluate the impact on product quality and regulatory compliance.
- Train and mentor internal teams and suppliers on quality systems and compliance expectations.
- Ensure alignment with global regulatory requirements (FDA 21 CFR Part 11/210/211, ISO standards, EU MDR, ICH guidelines).
Core Competencies & Skills
- Expertise in supplier quality management, auditing, and regulatory compliance.
- In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, IATF 16949 (if applicable).
- 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:
- Bachelor's/Master's degree in Engineering, Life Sciences, or related field.
- 10+ years of experience in supplier quality assurance, preferably in regulated industries.
- Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred.
- Six Sigma Green/Black Belt certification is a plus.
Proven track record in managing global suppliers and delivering measurable quality improvements.
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