Assistant Manager - Quality Systems - Medical Device Manufacturing

Urgent Requirement for Assitant Manager (Quality Systems)

JOB TITLE: Asst. Manager [ Quality Systems]

JOB SUMMARY : 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).

DUTIES AND RESPONSIBILITIES

- 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).

- 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).

- 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.

Experience

- Minimum 7 -8 years experience in Quality /QMS function, with at least 4years 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).

- External and internal audit extensive experience especially interacting and facing audits with Regulatory Bodies and the Food and Drug Administration (FDA) like US FDA.

- Statistical data analysis skills - Six Sigma GB / Lean certification will be added advantage

MINIMUM QUALIFICATION REQUIREMENTS : 

Education : 

- Bachelor's / Master's degree in Engineering or equivalent of education and experience enough to successfully perform the essential functions of the job may be considered.

Salary : Negotiable.

location : Trivandrum.

Call: 9061225511