Job Description
DePuy Synthes is recruiting for a Commercial Quality Specialist - India, located in Mumbai, India.
The Commercial Quality Specialist – India plays a critical leadership role in ensuring the effectiveness, compliance, and continuous improvement of the Quality Management System (QMS) and Health, Safety & Environment (HSD) programs across DePuy Synthes India operations. This role partners closely with regional and global Quality, Regulatory, and business leaders to safeguard product quality, employee safety, and regulatory compliance while enabling operational excellence. This is an exciting opportunity to make a meaningful impact by strengthening quality culture, driving risk-based decision making, and supporting business growth in a highly regulated medical device environment.
Key Responsibilities
•Lead and maintain the India QMS in alignment with global DePuy Synthes and Johnson & Johnson Quality & Compliance standards, applicable regulations, and internal policies.
•Oversee HSD programs to ensure compliance with local, regional, and company requirements, promoting a strong culture of safety and environmental responsibility.
•Serve as the primary quality and HSD business partner for India leadership, providing strategic guidance, risk assessments, and decision support.
•Lead internal and external audits, inspections, and assessments; ensure timely and effective remediation of observations and findings.
•Drive continuous improvement initiatives, including CAPA, management review, and quality metrics to enhance system effectiveness and compliance performance.
•Ensure effective change management, document control, and training programs across India operations.
•Collaborate with Regional and Global QARA partners to align India practices with enterprise strategies and regulatory expectations.
Qualifications
Education
•Bachelor's degree required in Engineering, Life Sciences, Quality, Environmental Health & Safety, or a related discipline.
•Master's degree or advanced qualification preferred.
Experience and Skills
Required:
•Minimum 5–8 years of progressive experience in Quality Management Systems and/or Health, Safety & Environment within a regulated industry (medical devices, pharmaceuticals, or healthcare preferred).
•Strong working knowledge of global and local quality and HSD regulations and standards (e.g., ISO 13485, ISO 14001, ISO 45001, and applicable Indian regulations).
•Demonstrated experience leading audits, inspections, and regulatory interactions.
•Proven ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels.
Preferred:
•Prior experience supporting manufacturing, distribution, or commercial operations in India.
•Experience working in a global or matrixed organization.
•Demonstrated success driving culture change and continuous improvement.
•Familiarity with digital quality systems and data-driven quality metrics.
•Strong problem-solving, risk management, and decision-making skills.
•Excellent written and verbal communication skills.
Other
•Language: Fluency in English required; proficiency in local languages preferred.
•Travel: Limited domestic travel; limited international travel as needed.
•Certifications: Lead Auditor, Quality, or HSE certifications (e.g., ISO Lead Auditor, NEBOSH) preferred.
Johnson & Johnson announced plans to separate its Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans.
