Senior Manager - Quality (Medical Device)
- Motherson
- 15 - 20 years
- Kanchipuram
- 3 months ago
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Job Description
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.
Job Classification
Industry: Medical Devices & EquipmentFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: MothersonLocation(s): Kanchipuram+ View Contact
Keyskills: FDA Regulatory Affairs QMS Medical Devices Regulatory Compliance Eu Mdr
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₹ 25-30 Lacs P.A
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