Quality Manager

Custom Search Inc.; Maple Grove (MN); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Custom Search Inc. is seeking a hands-on Quality Manager to lead day-to-day Quality Control operations in its specialized manufacturing environment. This role involves close collaboration with manufacturing teams to solve quality challenges and develop a capable quality team.

The ideal candidate will drive audit readiness, CAPA investigations, and continuous improvement across complex medical device processes while mentoring five quality professionals in a smaller, fast-moving organization.

Formación

• Bachelor's degree in Engineering or Life Sciences or Quality or related field.
• 7+ years of experience in Quality Engineering, Quality Control, Manufacturing Quality, or related medical device environment.
• Experience 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.
• Proven leadership experience mentoring and developing quality professionals.
• Strong understanding of manufacturing processes, inspection methods, testing, process controls, and quality systems.

Responsabilidades

• Oversee day-to-day Quality Control operations and release activities for materials and finished medical devices.
• Provide hands-on quality oversight across assembly, fabrication, and manufacturing processes for product quality and compliance.
• Maintain inspection documentation, traceability, and quality records to support FDA, ISO 13485, and regulatory requirements.
• Lead investigations, CAPA, root-cause analysis, and disposition of nonconforming materials and products.
• Manage, mentor, and develop a team of five quality professionals while balancing priorities and resources.
• Collaborate with cross-functional teams to ensure manufacturing training, qualification, and documentation requirements are met.
• Oversee quality activities in controlled manufacturing environments, including cleanroom compliance and environmental monitoring.
• Work with Supplier Quality Engineering to address supplier-related issues and incoming inspection requirements.

Conocimientos

Quality management

CAPA investigations

Root cause analysis

Regulatory compliance

Cross-functional collaboration

Hands-on leadership

Educación

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Descripción del empleo

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.

Your role with the company:

• 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.

Desired profile:

• 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.

Ideal experience:

• 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.