Asst. Manager – Quality Systems

8 - 10 Years

Job Description

Supports the activities for the development, implementation, monitoring and continuous improvement of Quality Management System, environment and health & safety management system programs, policies, processes, procedures and controls to achieve the companys objectives. Works closely with all other departments and business areas to ensure an effective and compliant quality system. Position oversees the CAPA Program, Quality System Training Program, Internal Audit Program and External Audit Program (including management of Supplier, Customer, Notified Body and Regulatory Agency audits and inspections).


Works as a primary liaison with the company for quality system program initiatives and process/system alignment; facilitates sharing best practices across regional locations.
Ensures that the Quality Management System is updated, maintained for effectiveness in accordance with applicable standards within scope of Quality Manual (including but not limited to ISO 13485, ISO 14971, ISO9001, ISO 14001, OHSAS 18001, Medical device rules India, MDD/MDR, CMDR, USFDA Guidelines -21 CFR, Drugs & Cosmetic Rules, India).
Supports continuous improvement of QMS by leading implementation efforts to new and changing requirements and process improvement initiatives.
Manages internal audit programs to maintain ISO certification and regulatory compliance.
Manages external regulatory compliance audits and relationships with industry groups, regulatory agencies and customers (e.g., FDA, Notified Bodies, Customers, Health Canada and other international regulatory agencies).
Ensures corrective actions and preventive actions (CAPA) are established, tracked and trended, and that root cause elimination is completed for identified issues by appropriate function.
Communicates to Management team emerging quality system issues related to internal/external audit, and CAPA trends.
Maintain all relevant documents related to Management Systems including issue of documents, control and amendments, review of records, audit reports, non- conformance reports and Corrective / Preventive actions.
Works with others to develop and implement effective training programs to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance.

Bachelors / Masters degree in Engineering or equivalent of education and experience enough to successfully perform the essential functions of the job may be considered.

Required Candidate profile


Minimum 7 -8 years experience in Quality / QMS function, with at least 4 years direct experience in the medical device manufacturing industry.
Preferred experience in Regulatory Compliance/Regulatory Affairs experience involving new changes as in European Regulations.
Experience in interfacing with global regulatory agencies (USFDA and or Notified Body inspections, audits or other similar regulatory body inspections).
Comprehensive knowledge of U.S., European and other international regulations, standards and guidance applicable to medical devices
Experience in interfacing with FDA and/or other regulatory agencies and Notified bodies, including preparing for and managing on-site external audits, responding to non-conformities and compiling formal responses (such as FDA 483s and warning letters).


Must have strong theoretical knowledge of the Quality Management System functions in all primary disciplines, including in-depth practical knowledge of how to apply these principles.
Extensive knowledge of international medical device regulations and standards.
Excellent written and oral communication skills and a proven ability to communicate effectively. Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.
External and internal audit extensive experience especially interacting and facing audits with Regulatory Bodies and the Food and Drug Administration (FDA) like US FDA.
Ability to use and teach methods necessary to facilitate Quality System design and continuous improvement across the company, including process mapping and redesign, project management, metrics selection and monitoring.
Statistical data analysis skills Six Sigma GB / Lean certification will be added advantage
Knowledge and use of relevant PC software applications and skills to use them effectively.

Certificates, Licenses, Registrations:
RAC Certification / Lead Auditor Certification

Salary: Not Disclosed by Recruiter

Industry:Medical Devices / Equipments


Desired Candidate Profile

Please refer to the Job description above

Company Profile

Terumo Penpol Pvt Ltd

Terumo Penpol personifies the story of a home grown R&D initiative commercialized successfully. Practicing the concept of � Quality First � approach in manufacturing, Terumo Penpol has been serving Blood Centers across the globe for more than thirty years. Partnering with Terumo Corporation, Japan, a global leader in healthcare products, has enabled Terumo Penpol to harness the combined strengths in Technology and Manufacturing to continue redefining standards in Blood Transfusion.With Terumo’s recent acquisition of Terumo BCT, Terumo has become the world leader in Blood Management. The Blood Transfusion division of Terumo is being re-organized under the newly acquired company which has been renamed as Terumo BCT. The Apheresis and Cellular Therapy products of Terumo BCT complements Terumo Penpol products to provide a full range of blood collection, storage and processing solutions for Hospitals and Blood Centres in India and other countries.
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Contact Company:Terumo Penpol Pvt Ltd


Reference Id:QSM-AM-1804

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