Quality Manager - Medical Devices (Hands-On Leader)

Custom Search Inc.; Maple Grove (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality management

CAPA investigations

Root cause analysis

Regulatory compliance

Cross-functional collaboration

Hands-on leadership

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Job description

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.