Senior Supplier Quality Engineer / Supplier Quality Trainer

Supplier Quality Professional

Job Responsibilities:

• Develop and manage supplier quality strategies, policies, and risk management processes.
• Lead

  supplier qualification, selection, and approval

  in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP).
• Conduct

  supplier audits, assessments, and performance reviews

  to ensure compliance with quality and regulatory requirements.
• Oversee

  supplier corrective and preventive actions (CAPA)

  , root cause analysis, and continuous improvement programs.
• Collaborate with cross-functional teams (procurement, R&D, operations, quality) to resolve supplier-related issues.
• Monitor supplier

  KPIs

  (on-time delivery, defect rates, deviations, complaints) and drive improvement initiatives.
• Support

  new product development (NPD)

  by ensuring supplier capability for components, raw materials, and services.
• Manage

  supplier change control

  processes and evaluate impact on product quality and regulatory compliance.
• Train, mentor, and guide 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

• 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, 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 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.
• Proven track record in

  managing global suppliers

  and delivering measurable quality improvements.