Qms Manager Jobs in Raleigh, NC (NOW HIRING)

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.

   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 to
o    Establish compliant and efficient complaint handling & adverse event reporting process across the company 
o    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
o    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
o    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
o    Work with Management throughout Teleflex to improve products and streamline processes and systems as needed 
o    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
o    Serve as PRRC for the reporting obligations referred to EU MDR Articles 87 to 91 
o    Support enterprise-wide audits, both directly (i.e. front room) and indirectly 
o    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

   Bachelor's degree in science, engineering, medical 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

   Organization Capability - Building organizational capability requires a focus on developing the skills, knowledge, and potential of both individuals and teams. It's critical to create a culture of learning and growth by providing ongoing development opportunities, mentoring, and feedback. Effective leaders identify and address skills gaps, ensuring that the team has the right expertise to meet current and future challenges. By aligning talent with organizational needs, leaders build a strong foundation for sustained success and adaptability.

   Cross-functional Alignment - Building cross-functional relationships and alignment is essential to driving coordinated, organization-wide success. Leaders must foster open communication, trust, and mutual respect across teams to break down silos and ensure shared understanding of goals and priorities. It's critical to actively engage stakeholders, listen to diverse perspectives, and align efforts through clear direction and shared accountability. By promoting collaboration and joint problem-solving, leaders help teams move in sync and deliver integrated solutions that support strategic objectives.

   Continuous Improvement - Driving continuous improvement means fostering a culture where learning, innovation, and adaptability are part of everyday work. Leaders must encourage teams to challenge the status quo, identify inefficiencies, and implement solutions that enhance performance and outcomes. It's critical to use data and feedback to inform decisions and to recognize both progress and lessons learned. By modeling a growth mindset and rewarding initiative, leaders empower teams to take ownership of improvements and contribute to sustained organizational excellence.

   Culture and Values - Upholding and modeling organizational culture and values is essential to building trust, engagement, and a sense of purpose. Leaders must consistently demonstrate integrity, inclusivity, and accountability in their actions and decisions, setting the tone for how others show up at work. It's critical to create an environment where individuals feel respected, supported, and empowered to contribute authentically. By recognizing and reinforcing behaviors that align with core values, leaders help embed the culture into daily operations and long-term success.

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