QMS Specialist

0001 MA01-ANDOVER-US9A; Bengaluru; Hybrid; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Philips in Bengaluru is hiring a QMS Specialist to support the establishment and maintenance of a compliant QMS. You will develop and revise QMS documents, work with cross-functional teams to resolve quality issues through root cause analysis and corrective actions, and report QMS performance metrics.

The role requires 6–10 years of experience, strong document control and QMS documentation skills, and familiarity with ISO 13485, FDA QMSR, and EU MDR. Training and audits experience is a plus.

Qualifikationen

• 6–10 years of experience in QMS
• Experience with document control and QMS documentation
• Knowledge of QMS standards and regulations (ISO 13485, FDA QMSR, EU MDR)
• Experience with audits and training processes

Aufgaben

• Support establishment of a compliant QMS for activities in scope
• Develop and revise QMS process documents (SOPs, quality manuals)
• Collaborate with cross‑functional teams to resolve quality issues through root cause analysis and corrective actions
• Collect and report data on QMS performance metrics and track non‑conformances

Kenntnisse

Document control

QMS documentation

Root cause analysis

Training

Data analysis

Ausbildung

BE/MSc

Tools

Windchill

PLM

Jobbeschreibung

Job Title QMS Specialist Job Description

Job title: QMS Specialist

Your role:

The QMS Specialist is responsible for supporting the establishment of a compliant and effective Quality Management System (QMS) for the activities in scope. The role participates in developing and revising QMS process documents, such as SOPs and quality manuals, ensuring their accuracy and currency. The role works under general supervision, and collaborates with cross-functional teams to resolve quality issues through root cause analysis and corrective actions. The role collects and reports data on QMS performance metrics and tracks non-conformance reports, contributing to continuous improvement activities.

You're the right fit if:

• 1. Experience: 6–10 years; mid-level professionals.
• 2. Skills: Strong experience in document control and QMS documentation, including use of PLM and electronic document management systems such as Windchill; managing controlled documents, revisions, approvals, and change workflows; and maintaining device master record (DMR) or equivalent product documentation files. Good understanding of QMS standards and regulations, including ISO 13485, FDA QMSR, and EU MDR; experience with QMS processes like training, and participation in internal and external audit. Participates in the effective deployment and continuous improvement of QMS processes in the assigned area/ areas such as document control, training, and audits, by providing technical expertise and ensuring compliance with regulatory standards. Collects, compiles, and reports data on QMS performance metrics, such as non-conformances, critical findings, and training completion rates, to support management in decision-making. Contributes to continuous improvement initiatives by identifying opportunities for enhancing efficiency and compliance within existing QMS processes and providing support in implementing improvements.
• 3. Education: Bachelor of Engineering and/or MSc. (Science, Biomedical, Biotech, etc)
• Anything else:
  • Regulatory Requirements
  • Quality Management Systems (QMS)
  • Troubleshooting
  • KPI Monitoring and Reporting
  • Data Analysis & Interpretation
  • Process Improvements
  • Agile Methodology
  • User Training & Support
  • Training Content Development
  • Business Acumen

Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is €[Min]–€[Max]. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you’ll have in this role, alongside internal equity and local market considerations. This role is eligible for [bonus/incentive], with your rewards linked to [KPIs/company results]. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision. Benefits include [key benefits].

How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

About Philips

Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose. Learn more about our culture of impact with care. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.

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