Sr. Manager, Product Quality Assurance

Teleflex•Durham, NC

3d•Onsite

About The Position

Teleflex is seeking a Sr. Manager, Product Quality Assurance. The candidate will manage Post-Market Surveillance for medical device complaints, including Complaint Intake, Sample Investigations, Adverse Event Reporting, and Complaint risk reviews. They will ensure timely management and escalation of product quality concerns from post-market surveillance. The successful candidate will liaise cross-functionally to drive the investigation, escalation and resolution of post-market events. As a People Manager, you play a pivotal role in leading, developing, and inspiring a high-performing team to deliver exceptional results aligned with organizational goals. You are responsible for building organizational capability through effective talent development, fostering a culture of accountability, and promoting continuous improvement. Your role requires strong cross-functional collaboration to ensure alignment and drive integrated solutions across the business. As a leader, you are a visible champion of our culture and values, creating an inclusive, purpose-driven environment where individuals feel empowered to contribute and grow.

Requirements

Bachelor’s degree in science, engineering, medical or or equivalent experience required
Minimum 7 years experience in the medical device industry in quality assurance/quality engineering functions commensurate with the responsibilities outlined above
Extensive knowledge and understanding of international Quality and Regulatory standards and regulations, including but not limited to FDA's 21 CFR Part 820 & 803 (Quality System Regulation), ISO 13485 Quality System requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL requirements
Minimum 5 years experience in managing teams, specifically Post Market Surveillance, Complaint Handling, Vigilance Reporting or Regulatory Affairs
Experience of performing and/or hosting internal and external audits
Excellent attention to detail and the ability to communicate clearly and accurately, verbally and in writing
Knowledge and experience with corrective and preventive actions systems
Knowledge and experience in process monitoring methods and techniques
Exceptional leadership skills and proven experience in leading, advising, inspiring, educating, and developing high-performance teams
Excellent interpersonal and communication skills with the ability to communicate effectively across all areas of business
Skill in identifying complex problems and reviewing related information to develop and evaluate options and implement solutions
Must display initiative in anticipating and meeting or exceeding the business demands of senior-level executives
Strong business partnering skills and holistic view of business strategy, processes, and objectives.
Advanced skills in the Microsoft office. Experience with QMS electronic applications, e.g. Agile, SAP, Veeva

Responsibilities

Oversee complaint investigation team and laboratory to ensure appropriate policies and practices are implemented for physical sample returns & investigations
Responsible for the Teleflex Complaint Administration and Reporting processes and procedures, including but not limited too Establish compliant and efficient complaint handling & adverse event reporting process across the company
Ensure systems/databases (e.g. SAP, Veeva Vault, Agile, etc.) for centralized complaint administration, trending, and reporting meet complaint management needs. Work with stakeholders to adapt and revise processes as needed to ensure ongoing compliance with standards and regulations
Work with global counterparts, especially Teleflex regional regulatory partners, to enact compliant and effective processes that ensure timely processing & submission of complaints in each region
Implement practices for complaint queries (addition information requests), follow-up and completion of appropriate responses and tracking
Responsible for the Teleflex Complaint data and internal KPI tracking to support QMS, KPIs and corporate targets and objectives
Work with Management throughout Teleflex to improve products and streamline processes and systems as needed
Collect, summarize, and evaluate data for reporting to Sr. Management, including via management review meetings
Manage the escalation and compilation of information necessary for post-market risk assessments (e.g. Health Hazard Evaluations, complaint trends) for executive management to assess if field actions/corrections and removals associated with Teleflex products are warranted
Lead and develop complaint handling subject matter experts for audits, management reviews, and electronic QMS implementation
Serve as PRRC for the reporting obligations referred to EU MDR Articles 87 to 91
Support enterprise-wide audits, both directly (i.e. front room) and indirectly
Communicate with FDA, competent authorities or other interested internal and external parties as needed
Coach and support CAPA, NC, & complaint trend owners to ensure QMS compliance, serve as quorum on QMS reviews, including but not limited to CAPA, NCRB, Product Quality or Management Reviews
Lead improvements utilizing data and performance to identify program weaknesses and make continuous improvements in procedures, staffing, or oversight of the function
Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures
Complete other duties and tasks as assigned