Senior Supplier Quality Engineer

3 weeks ago

Bengaluru, India Tek Support Full time

Job Title: Senior Supplier Quality

Location:
Bengaluru, Karnataka, India

Employment type:
Part-time

Job Summary:

We are seeking an experienced
Supplier Quality Professional
Trainer
with 10+ years of expertise in managing
supplier quality assurance
, supplier development, and compliance in regulated industries (pharmaceutical, biotech, or medical devices). The role involves ensuring
suppliers meet company
, industry, and regulatory standards by
leading audits, driving quality improvement initiatives
, and building strong supplier partnerships.

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 the 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 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:

  • 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.

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