Quality Manager

We've partnered with a growing, innovative medical device company that is adding a Quality Manager to lead day-to-day Quality Control operations within its highly specialized manufacturing environment.

This is a hands-on leadership opportunity for someone who enjoys being close to the manufacturing process, solving complex quality challenges, and developing a team.

You'll lead a team of five quality engineering and inspection professionals while overseeing inspection, testing, compliance, and quality activities across complex medical device manufacturing processes.

As the company advances through pivotal clinical trials and prepares for future commercialization, you'll play an important role in maintaining quality standards, driving continuous improvement, and ensuring audit readiness.

This is an excellent opportunity for someone who thrives in a smaller, collaborative environment where they can make an immediate impact.

• Quality Control Operations:
  Oversee daily inspection, testing, and release activities for incoming materials, in-process components, and finished medical devices.

• Manufacturing Quality:
  Provide hands-on quality oversight across complex assembly, fabrication, and manufacturing processes, ensuring product quality and compliance.

• Audit Readiness & Compliance:
  Maintain inspection documentation, traceability, and quality records to support FDA, ISO 13485, and international regulatory requirements.

• Nonconformance & CAPA Management:
  Lead investigations, root-cause analysis, corrective actions, and disposition of nonconforming materials and products.

• Team Leadership:
  Manage, mentor, and develop a team of five quality professionals while balancing daily operational priorities and resource needs.

• Training &
  
  Qualification:
  
  Partner with cross-functional teams to ensure appropriate manufacturing training, qualification, and documentation requirements are maintained.

• Process & Environmental Controls:
  Oversee quality activities associated with controlled manufacturing environments, including cleanroom compliance, environmental monitoring, and process controls.

• Supplier Quality:
  Collaborate with Supplier Quality Engineering to address supplier-related issues, corrective actions, and incoming inspection requirements.

• Cross-Functional Collaboration:
  
  Work closely with Manufacturing, Engineering, Operations, and Regulatory Affairs to resolve quality issues and support continuous improvement.

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical field.

• 7+ years of experience in Quality Engineering, Quality Control, Manufacturing Quality, or a related medical device environment.

• Experience working in FDA-regulated medical device manufacturing, with knowledge of 21 CFR Part 820 and ISO 13485.

• Experience leading nonconformance investigations, CAPA, root-cause analysis, and corrective actions.

• Previous experience managing, mentoring, and developing quality professionals.

• Strong understanding of manufacturing processes, inspection methods, testing, process controls, and quality systems.

• Ability to be hands-on, prioritize competing demands, and solve problems in a fast-paced manufacturing environment.

• Strong communication and cross-functional collaboration skills.

• Experience with Class III medical devices, particularly implantable or cardiovascular devices.

• Experience supporting complex, high-precision medical device manufacturing or assembly processes.

• Background in cleanroom manufacturing, environmental monitoring, or bioburden testing.

• Experience supporting clinical-stage medical devices transitioning toward commercialization.

• Familiarity with MDSAP, CE Mark, and Health Canada requirements.

• Experience with supplier quality activities, including SCARs and incoming inspection.

• Previous leadership experience in a start-up or growing medical device organization.