Senior Manager/ Head of QA (Medical Device)

Software Guidance & Assistance, Inc., (SGA), is searching for a Senior Manager/ Head of QA (Medical Device) for FULL TIME assignment with one of our premier Pharmaceutical Services clients in Billerica, MA.

Join a growing Compliance Team working on Blu U light device.

Will have no direct reports at this time.

Our benefits include:

6 weeks PTO/Holiday

401(k) company match

Great health insurance rates

Relocation assistance

Responsibilities :

• 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 firm Corporate Audits.
• Responsible as "Management Representative”, leading all regulatory inspections related to medical device and combination products (FDA/ISO).
• Lead Management Review meeting ensuring the Quality Management Systems (QMS) is suitable and effective.
• Review and approve Device History Records related to medical device products.
• Oversite and continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations.
• Work directly on technical investigations relating to medical device Quality Complaints.
• Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries.
• Provide oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendor/supplier.
• Participate in all vendor/ supplier change notification review and approvals.
• Ensure Annual supplier/vendor assessment, maintenance of supplier/vendor audit schedule, status tracking and approved supplier list (ASL).
• Review and approve all medical device related documents as authorized and describe by procedures.
• Manage electronic Quality Management System (Track Wise)
• Author/revise standard operating procedures (SOPs) related to medical device and associated systems aligning with regulatory guideline and corporate policy as required.
  
  

Required Skills:

• Bachelor's degree in Science or related scientific fields.
• Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.
• Strong knowledge of medical device 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.
• 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.
  
  

Preferred Skills:

• Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred.
• Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc.
  
  

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.