Quality Systems Manager
Careers that Change Lives
At Medtronic Renal Care Solutions (RCS), we are working on new therapies for End Stage Renal Disease. Our R&D team spread across US, Italy, India and China working on an innovative Hemodialysis System that would expand clinical access to thousands of patients worldwide. RCS is looking to hire a talented and motivated quality individual to join our Quality Organization at our Bangalore, India site (MIDC).
The Quality Systems Manager shall be designated Site Manger with QMS, CAPA, Training, Audits, Supplier Controls and Design Quality. This person will work in collaboration with a global program team based in India, Italy, USA and China, to ensure the QMS is compliant with Medtronic Corporate processes and ISO 13485, and be Quality point of contact for the site to bring the new dialysis system to market.
Position Responsibilities
Responsibilities may include the following and other duties may be assigned:
Provide oversight and lead the development and maintenance of quality systems processes and procedures to ensure compliance with policies with established internal and external standards and regulations.
- Assist with Management Review meetings including generation of quality metrics and coordinating the review.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal procedures to assure compliance for RCS QMS.
- Lead audit and inspection preparation, resolution of audit and inspection findings with relevant stakeholders through all stages of the audits.
- Co-ordinate CAPA’s meetings and provide assistance to the corrective action owners to ensure effectiveness.
- Ensure supplier qualification requirements are being followed by reviewing supplier assessments and quality agreements as required by corporate policy and RCS QMS.
- Ensure employee training compliance to Corporate and site-level QMS. May be responsible for preparing and facilitating quality related training programs for employees.
- Experience in coaching and developing direct reports, utilizing performance management tools and disciplines while increasing employee engagement and retention.
Basic Qualifications
Education Required
Bachelor’s Degree in engineering or technical discipline
Years of Experience
- 14+ years’ experience in Quality compliance or Quality Management Systems in medical device and/or pharma industry.
- 4+ years of people management experience
- Strong knowledge in ISO 13485, EU MDR and U.S. 21 CFR Part 820, 211, 21 CFR 210, 21 CFR 4 regulations for medical devices and pharma products.
- QMS auditor certification
- Knowledge of various QMS tools such as Agile PLM, PQM etc.
- Demonstrated ability to coach and provide feedback
- Able to work independently and in a team environment
- Ability to interface with internal customers, suppliers and regulatory agencies
- Demonstrated CRITICAL THINKING skills with focus on improved system performance outcomes and positive business impact
- Excellent PROBLEM-SOLVING skills, including demonstrated application of structured problem solving methods and tools
- Strong written and oral COMMUNICATION skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
- Strong COLLABORATION and INFLUENCE skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole)
