Job Description:

Job Summaryfor all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established pliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR98-282), EU Medical Device Regulation 2017745.site readiness for regulatory agency inspections andor Sun Corporate Audits.Area Of Responsibilityas "Management Representative", leading all regulatory inspections related to medical device and combination products (FDAISO).Management Review meeting ensuring the Quality Management Systems (QMS) is suitable and effective.and approve Device History Records related to medical device products.and continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations.directly on technical investigations relating to medical device Quality Complaints.verbal and written responsesresolutions to customers regarding product quality Complaints or product inquiries.oversight of the vendorsupplier management Program and work closely on device issues and develop quality vendorsupplier agreements with all key vendor all vendor supplier change notification review and approvals.Annual suppliervendor assessment, maintenance of suppliervendor audit schedule, status tracking and approved supplier list (ASL).and approve all medical device related documents as authorized and describe by procedures.electronic Quality Management System (Track Wise)standard operating procedures (SOPs) related to medical device and associated systems aligning with regulatory guideline and corporate policy as requiredOther duties as assignedWork Conditions:Office Manufacturing FloorWarehouseThird Party site (as required)Physical Requirements:Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balanceTalk or hearClose and clear visionComputeroffice machines Lift up to 10 lbs. Some travel outside of company facility as requiredMust wear personal safety equipment (gloves, lab coat, gowning, safety glasses) Travel EstimateUp to 5%Education and Job Qualification degree in Science or related scientific fieldsknowledge of medical devise regulations including 21 CFR 4, 21 CFR 210211, 21 CFR 820, ISO 13485, EU MDR (2017745), CMDR (SOR98-282).ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability.understanding and deployment of modern root cause and problem solving techniques such as statistical process controls and quality function deployment.understanding of medical device QA principles, industry practices, and standardsability of multi-task and manage completing priorities.strong ability in problem solvingSuperior internal and external customer servicepeople skillsAbility to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner.Ability to work both independently and collaboratively in team structure. Excellent verbal and written communication skills, including ability to influence others. Excellent organizational and time management skills with a high level of attention to detail. Experience8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.knowledge of medical devise regulations including 21 CFR 4, 21 CFR 210211, 21 CFR 820, ISO 13485, EU MDR (2017745), CMDR (SOR98-282).in leading andor supporting medical device regulatory inspections by FDA and Health Canada, corporate audits and third party audits.knowledge of review and approve device history records related to medical devices.knowledge of handling of medical device related complaints.of vendorsupplier management Programknowledge of Trackwise to handle electronic Quality Manage System (eQMS) data, EDMS for SOPs and LMS for trainings.working knowledge of MS Office software.knowledge to handle SAP, EDMS, LMS, Master Control etc...with the manufacture and testing of radiopharmaceuticals is strongly preferred.Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual departmentteam performance, and market factors.The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.Notice to Agency and Search Firm Representatives:Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies andor search firms for this job posting. Resumes submitted to any Sun employee by a third party agency andor search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.