Commercial Quality Specialist

Johnson & Johnson Co.; Mumbai; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Johnson & Johnson's DePuy Synthes India in Mumbai seeks a Commercial Quality Specialist to lead QMS alignment, HSD programs, and regulatory compliance in a highly regulated medical device environment.

You will partner with India leadership and global QARA teams to drive risk-based decision making, CAPA, audits, and continuous improvement, shaping quality culture across operations.

Qualifications

• 5–8 years of experience in Quality Management Systems in a regulated industry.
• Knowledge of ISO 13485, ISO 14001, ISO 45001 and Indian regulations.
• Experience leading audits and regulatory interactions.
• Ability to influence stakeholders at multiple levels.

Responsibilities

• Lead and maintain India QMS per global standards.
• Oversee HSD programs ensuring safety and environment compliance.
• Partner with India leadership providing guidance and risk assessments.
• Lead audits, inspections, and remediation of findings.
• Drive CAPA, management reviews, and quality metrics.
• Ensure document control and training programs.
• Collaborate with regional and global QARA partners.

Skills

Quality Management

Audits

Regulatory Knowledge

Cross-functional

Risk Assessment

Education

Bachelor's degree

Master's preferred

Tools

ISO 13485

ISO 14001

ISO 45001

QMS software

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Mumbai, India

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 our 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. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing