QA (RA) Executive
Job Description:
Former experience in the following:
- Working in Medical Device: Initiate, monitor, and verify the effective implementation of the Quality Management System in all areas of company activities
- Regulatory submissions: Regulations requirements of the ISO 13485; FDA; CE (MDD/MDR) and MEDDEV
- Composing and maintaining quality manual procedures (i.e., SOP’s), Follow the requirements of GLP/GMP.
- Internal and external audits, inspections.
Quality Assurance
Implementation and management of all QA activities which includes:
- Quality System Tools administration, training and auditing [as Customer Complaints/CAPA/Training/Control Documents/Standards].
- Verify the compliance of quality procedures and working instructions with predefined and new mandatory standards.
- Ensure that the Company’s quality assurance and control system complies with the procedures and working instructions through audits, training, preventive and corrective actions.
- Maintaining the training, qualification, and certification records of Company personnel including developing, determine and conduct training and certification subject to the Quality Manual.
- Approve / disapprove suppliers and vendors of goods and services subjected to the Quality Manual.
- Approve / disapprove facilities, equipment, processes, and materials subjected to the Quality Manual.
Regulatory Affairs:
- Regulatory submissions in various countries.
- Regulations requirements support to all areas of company activities.
- Define and conduct tests, bench tests and experiments to support regulatory requirements.
- Marketing, Social media material and labeling review & approval.
Company Profile
It is, an ISO 9001: 2015 and an American Petroleum Institute (API) Member company, is one of industry leaders in the design and manufacture of Specialty Heat Recovery equipments, Distillation Trays & Internals, Dampers and Guillotines. With approvals from most of the process licensors and end-users globally, --- products include Air Preheaters, Column Trays & Internals, Dampers, Guillotines, Shut-off Blades and Igniters supplied to Oil Refineries, Petrochemical, Power, Fertilizer and Chemical Plants. --- is proud of its quality conscious workforce, a well equipped fabrication shop and a completely automated foundry plant located in Haryana, India, about 125 miles
Telephonic Interview Available
- Telephonic interview are scheduled for this job opening.
- Interested Candidates are requested to apply and get recruiter contact number for telephonic interview.
- Candidates can call recruiter on given contact to start telephonic interview during working hours.