Senior Manager - Quality (Medical Device)

Required Level Of Experiences

• At least 15-20 years experience in relevant industry like Medical Device Or Healthcare with ISO 13485, 21CFR 820 or cGMP regulated environment with Experience in Regulatory certifications & bodies.
• Proven problem solving, trouble shooting and Outcome focused Mindset.
• Experience with Quality Tools, leading Medical devices Cross functional teams in Product Quality improvements and certification activities.
• Experience in eQMS, CSV (Computer system Validation) & working with certifying bodies to submit required documentation to enable QMS certifications.

Knowledge and educational level

• BE or BTech. or high or equivalent Degree. MBA is added preference.
• Working Knowledge on effective QMS deployment, Quality tools & Resources.
• Certifications Ex: ASQ Quality Engineer certifications.
• Working knowledge & experience of Quality Tools for Statistical Analysis.
• Should have excellent People management & Communication skills.

Key areas of accountability/responsibility

• Provide leadership and direction for the leadership functions. Ensure Compliant Quality Culture, open and effective communication in the Business around global locations.
• Liaison with all external regulatory & certifying bodies to enable certifications and its audits.
• Periodic reporting of health of the Products across Business to the top management.
• Ensure the manufacturing facility & Product Development teams are trained and follows GDP, GMP, technically sound, safe and environmentally acceptable manner by complying with Quality Policy & ISO 9001,13485 requirements and other relevant regulations and best practices.
• Ensure Quality Culture Mindset development within the larger organization.
• Ensuring Training within organization in adherence to the applicable regulations & enabling the same within the QMS established.
• Documentation support to facilitate ISO 13485, FDA license and Schedule M compliance.
• Select, manage coach and develop staff, in line with Motherson values and HR requirements and procedure.
• Effectively engage in NPI activity to outline the component, product or services Quality requirement from day one. To build and develop best in class quality team in Health & Medical division including its supplier base.