Quality Systems Manager

Nextern•Maple Grove, MN

About The Position

NPX Medical, a division of Nextern, is a global medical device development and manufacturing platform specializing in precision metal components and assemblies, including nitinol engineered components, precision laser cutting and processing, and advanced catheter technologies. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture medical devices across the product lifecycle. The Quality Systems Manager is responsible for strategy deployment, alignment, and standardization of the Quality Management System and the Quality Systems Team, including engineers, technicians, and inspectors. The role owns audits, certifications, and ongoing relationships with the company’s notified body and regulatory agency registration processes. It coordinates global leadership teams to resource and prioritize initiatives related to facility certification business strategies and oversees programs, policies, processes, procedures, and controls that ensure product performance and quality meet established standards and agency regulations. This position directly supervises the Quality Systems Team and manages its staffing and performance, including interviewing, hiring, training, work assignment, performance appraisal, rewards and discipline, and resolution of complaints and problems. The manager is expected to work effectively in a fast-paced, changing team environment and demonstrate strong organizational, planning, and follow-up skills, including the ability to hold others accountable.

Requirements

Bachelor’s degree in a STEM-related field.
7+ years of relevant experience in ISO 13485 and FDA GMP.
2+ years of Quality management experience.
Excellent written and oral communication skills.
Experience configuring reports, security/access, data structuring, metadata fields, and workflows.
Medical device experience.
Strong organizational, planning, and follow-up skills, with the ability to hold others accountable.
Ability to work effectively within a team in a fast-paced, changing environment.

Nice To Haves

Experience implementing foundational and expandable quality system strategies in a small- to mid-size company.
Project management experience transitioning to the ISO 13485:2016 standard.
Project management experience implementing eQMS systems.
Training or certification in Lean and Six Sigma.
Training or certification in lead auditing ISO 13485 and FDA GMP systems.
Previous CDMO experience.

Responsibilities

Manage relationships between NPX Medical and its ISO notified body.
Manage the Quality Systems Team in establishing scalable, compliant systems and processes, including CAPA, Change Control, Document Control, Customer Feedback, and Training.
Support customer, internal, and regulatory audits.
Lead compliance initiatives for core QMS processes and standardize quality metrics.
Define and communicate the department’s overall vision and cascade objectives.
Develop, train, implement, and continuously improve company and business unit policies and procedures.
Provide timely performance and developmental evaluations for departmental staff.
Directly supervise Quality Systems Team employees, including interviewing, hiring, training, planning and assigning work, directing work, appraising performance, rewarding and disciplining employees, and addressing complaints and resolving problems.
Coordinate global leadership teams to resource and prioritize initiatives related to facility certification business strategies.
Oversee programs, policies, processes, procedures, and controls to ensure product performance and quality conform to established standards and agency regulations.