Manager Quality Assurance preferred from Medical Device Industry

from 10 to 16 year(s) of Experience
₹ 6,00,000 - 12,00,000 P.A.

Job Description

Roles and Responsibilities

Designation:Manager Quality Assurance preferred from Medical Device Industry

Reports to: Director

Industry: Medical Devices/ Automobile Industry

Place of Posting: Sonepat 2 KM from Delhi Border

Pick & Drop available from Jahangir Puri & Pitampura metro


Job Responsibilities & Duties

  • Plan, establish and maintain a quality management system in accordance with ENISO 13485 and MDSAP.
  • Develop standardized production, quality, and customer-service standards.
  • Identify potential risks before they become a problem, focusing on root cause analysis and preventive action.
  • Identify and implement CAPA for non-conformance observed during any stage of the lifecycle of medical device, in internal/external audits or as a product complaint.
  • Ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control and ISO Standards.
  • Training and ensuring all assigned employees are aware of and comply with company policies, government procedures, and regulations.
  • Working closely with product development and product transfer teams.
  • Releasing final product and disposition of Non-conforming material.
  • Maintain product traceability and finished goods release processes.
  • Support projects and new product introductions by establishing key checkpoints for new products and processes.
  • Supplier audit and Qualification.
  • Responsible for all clean room, and packing activity as per the QMS requirement.
  • Build a strong team through coaching, mentoring, specific training and performance evaluations.
  • Any other duties as assigned.
Key Skills:

Quality Assurance, QMS, QPs, ISO 13485, ISO 14971, MDSAP, RCA, CAPA, Audits, US FDA, Design Control, ISO Standards, Dispose Non-Conforming Material, Product Traceability, Finished Goods Release Processes, NPD



Desired Candidate Profile

  • Bachelors/Master’s degree in Mechanical Engineering.
  • 10+ year relevant work experience from Medical Devices & Automotive Industry.
  • Must have ISO 13485:2016 internal Auditor certificate
  • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
  • Excellent computer and internet search skills.
  • Strong ability to multi-task and to meet business deadlines.
  • Excellent organizational skills with an ability to think proactively and prioritize work.

Key Skills:

Quality Assurance, QMS, QPs, ISO 13485, ISO 14971, MDSAP, RCA, CAPA, Audits, US FDA, Design Control, ISO Standards, Dispose Non-Conforming Material, Product Traceability, Finished Goods Release Processes, NPD



Role:Quality Assurance/Quality Control Manager

Salary: 6,00,000 - 12,00,000 P.A.

Industry:Medical Devices & Equipment

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Employment Type:Full Time, Permanent

Education-

UG:B.Tech/B.E. in Plastics, Automobile, Production/Industrial, Instrumentation, Biomedical, Mechanical, Metallurgy

PG:Post Graduation Not Required

Doctorate:Doctorate Not Required

Company Profile

Bee5 Manpower Consulting

The company is a global leader in Medical Devises and reflection of deep domain expertise in all aspects of Medical Devises in Orthopedics range. Within seven years of its inception, with distinguishable quality and value advantage delivered by its generic orthopedic implants has earned it the credibility to afford a rapidly expanding customer base, opportunities to provide OEM services to leading names in the industry as well as the confidence of the medical community at large. By establishing strong foundation of proven customer satisfaction, the company is focused on building a world of exciting possibilities in Research and Development, innovation, customization and education.
Company Info
View Contact Details+

Contact Company:Bee5 Manpower Consulting

Reference Id:Manager Quality Assurance preferred from Medical Device Industry

Website:http://www.bee5manpowerconsulting.com