Senior Manager, Quality Assurance - Medical Device

Job Summary

Responsible for 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 specifications.

• Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210 / 211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR / 98-282), EU Medical Device Regulation 2017 / 745.
• Ensure site readiness for regulatory agency inspections and / or Sun Corporate Audits.

Area Of Responsibility

• as Management Representative , leading all regulatory inspections related to medical device and combination products (FDA / ISO).
• 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 responses / resolutions to customers regarding product quality Complaints or product inquiries.
• oversight of the vendor / supplier management Program and work closely on device issues and develop quality vendor / supplier agreements with all key vendor / supplier.
• in all vendor / supplier change notification review and approvals.
• Annual supplier / vendor assessment, maintenance of supplier / vendor 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 required
• Other duties as assigned
Work Conditions :
• Office
• Office
• Manufacturing Floor
• Warehouse
• Third 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 balance
• Talk or hear
• Close and clear vision
• Computer / office machines
• Lift up to 10 lbs.
• Some travel outside of company facility as required
• Must wear personal safety equipment (gloves, lab coat, gowning, safety glasses)

Travel Estimate

Up to 5%

Education and Job Qualification

• Bachelor’s degree in Science or related scientific fields
• Strong knowledge of medical devise regulations including 21 CFR 4, 21 CFR 210 / 211, 21 CFR 820, ISO 13485, EU MDR (2017 / 745), CMDR (SOR / 98-282).
• Demonstrated ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability.
• Demonstrated understanding and deployment of modern root cause and problem solving techniques such as statistical process controls and quality function deployment.
• Excellent understanding of medical device QA principles, industry practices, and standards
• Demonstrated ability of multi-task and manage completing priorities.
• Demonstrated strong ability in problem solving
• Superior internal and external customer service / people skills
• Ability 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.

Experience

• Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.
• Strong knowledge of medical devise regulations including 21 CFR 4, 21 CFR 210 / 211, 21 CFR 820, ISO 13485, EU MDR (2017 / 745), CMDR (SOR / 98-282).
• Experience in leading and / or supporting medical device regulatory inspections by FDA and Health Canada, corporate audits and third party audits.
• Strong knowledge of review and approve device history records related to medical devices.
• Strong knowledge of handling of medical device related complaints.
• Knowledge of vendor / supplier management Program
• Working knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data, EDMS for SOPs and LMS for trainings.
• Strong working knowledge of MS Office software.
• Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc
• Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred.

The presently-anticipated base compensation pay range for this position is $140,000 - $150,000 + 15 bonus target. 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 department / team 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 and / or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and / or 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.