Team Lead, GPM Quality Assurance (Hybrid - Acton, MA)

Position Overview:

The Team Lead, Quality Assurance is a hands-on technical leader serving as a post-market surveillance quality assurance subject matter expert and representative.  This role will provide direction to individuals who are responsible for the review of documented files ensuring the files meet quality compliance standards, regulatory requirements, technical accuracy, and conformity to company policies and procedures. The role involves system level comprehension, attention to detail, organization, and constant interaction within the business to the accomplishment of the company goals. 

Responsibilities:

• Mentor and help develop direct reports through yearly/quarterly reviews, weekly meetings, and daily interactions.

• Support a positive culture with clear communication regarding goals and objectives

• Provide leadership to team members, including but not limited to, training support on process and procedures.

• Provide coaching and feedback in accordance with company SMART goals.

• Review complaint files to ensure proper complaint coding and accurate complaint reportability assessment. 

• Support database development and reporting capabilities related to the complaint / reliability department needs.

• Participate in calibration sessions with leadership to ensure consistency in assessments.

• Identify and assess trends in Quality Monitoring results.

• Deliver monthly presentations of Quality Monitoring results to the team.

• Suggest process improvements or enhancements to monitoring programs, internal processes, and procedures.

• Provide coaching support to staff based on Quality Monitoring findings.

• Coordinate with the training team to provide feedback on training opportunities identified through quality analysis.

• Lead projects that enhance and support the QA function within GPM.

• Lead or contribute to departmental non-conformances, events, and CAPAs.

• Perform other duties as required.

Education and Experience: 

• BS degree, preferably in a technical or scientific discipline; and/or equivalent combination of education and experience. 

• 2-3 years Complaint handling experience, Quality Assurance, or Regulatory Affairs.

• Minimum of 3 years’ experience in data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management. 

Preferred Skills and Competencies:        

• Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work

• Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision

• Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements

• Ability to generate, verify, and maintain accurate records

• Excellent verbal, written, and interpersonal communication skills.

• Exceptional listening and analytical skills

• Experience in CAPA, root cause analysis, or analytics

• Solid time management skills

• Must be able to work independently while contributing to the goals of the team.

• Must be proficient with Microsoft Office (intermediate Word, Excel)

• Willingness to pursue additional learning and build qualifications in a professional field, as required

• The ability to rapidly learn and take advantage of new concepts and adjust priorities as needed

• Experience with Corrective Action/Preventive Action preferred

• Experience with TrackWise

Physical Requirements (if applicable):