Quality Systems Manager

Nextern; Maple Grove (MN); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health Care Plan

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND 生日休假

Lifetime Membership Subsidy and Wel­l­

Life Insurance (Basic, Voluntary & AD&

Family Leave (Maternity, Paternity)

Short-Term & Long-Term Disability

Taco Thursdays!!!

Job summary

NPX Medical, a division of Nextern, is seeking a Quality Systems Manager to lead the Quality Management System, align with regulatory agencies, and coordinate global initiatives. The role oversees CAPA, Change Control, Document Control, and audits to ensure product quality and regulatory conformity.

The ideal candidate has a STEM degree with 7+ years in ISO 13485 and FDA GMP, and 2+ years in quality management, plus strong communication skills.

Qualifications

• 7+ years of ISO 13485 and FDA GMP experience.
• 2+ years of Quality management experience.
• Excellent Written & Oral Communication Skills.

Responsibilities

• Directly manage relationships with the ISO notified body.
• Lead Quality Systems Team and establish scalable, compliant processes (CAPA, Change Control, Document Control, Customer Feedback, Training).
• Oversee audits and regulatory readiness for internal and external assessments.
• Define and cascade department objectives and vision.
• Develop and implement company policies and procedures; provide timely staff evaluations.
• Supervise staff and manage hiring, training, and development.

Skills

Quality management

ISO 13485

FDA GMP

Regulatory audits

Documentation

Communication skills

Education

Bachelor’s degree in STEM

Job description

NPX Medical is a division of Nextern — a global, vertically integrated medical device development and manufacturing platform. We specialize in precision metal components and assemblies, with deep expertise in nitinol engineered components, precision laser cutting and processing, and advanced catheter technologies. Our engineers bring decades of combined experience — from R&D and rapid prototyping through full commercial production.

At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

The Quality Systems Manager will be responsible for strategy deployment, alignment, and standardization of the Quality Management System and Quality Systems Team (engineers, technicians, and inspectors). You will own the audit, certification, and relationship maintenance of the company’s notified body and regulatory agency registration processes and coordinate global leadership teams to properly resource and prioritize initiatives relating to facility certification business strategies. You will oversee the programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency regulations.

RESPONSIBILITIES:

• Directly manage the relationships between NPX Medical and their ISO notified body.
• Directly manage the Quality Systems Team in effectively establishing scalable and compliant systems and processes (i.e. CAPA, Change Control, Document Control, Customer Feedback, Training, etc) and supporting Customer, Internal & Regulatory Audits.
• Lead compliance initiatives for core QMS processes and standardization of quality metrics.
• Define and communicate overall vision and cascade objectives for the department.
• Develop, train, implement and continuously approve upon company and business unit policies and procedures.
• Provide timely performance & developmental evaluations of departmental staff.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Directly supervises employees within the Quality Systems Team.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Required:

• 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 & Oral Communication Skills.
• Experience with configuration of reports, security/access, data structuring, meta-data fields, and workflows.
• Medical device experience

Preferred:

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

Salary range: $120,000 to 160,000 depending on skills and experience

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nexternis an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.