
Senior Supplier Quality Engineer
2 days ago
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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