Medical Device Quality Systems Lead

Cretex Medical Component and Device Technologies; Brooklyn Park (MN); On-site; USD 62,000 - 93,000; Full time

Benefits offered by this job

401k match

Onsite health clinics

Cretex University

Employee assistance program

Holiday bonus program

Wellness program

Job summary

Cretex Medical is seeking a Quality Systems Specialist to develop, implement, and maintain the quality management system. The role supports ISO and FDA compliance, leads audits, and drives CAPA programs across the organization.

You will collaborate with quality, operations, engineering, and finance to ensure processes meet customer and regulatory requirements while fostering continuous improvement in a fast-paced environment.

Qualifications

• Bachelor’s degree in a related field or equivalent relevant experience.
• 3 years of experience with quality management systems.
• Experience with ISO 13485:2016 and FDA.
• Lead Auditor Certification.
• Ability to manage multiple tasks and prioritize work.
• Strong attention to detail and communication skills.

Responsibilities

• Assist or lead internal and supplier audits, including preparation and follow-up.
• Implement and monitor CAPAs from audits and investigations.
• Maintain and improve the Global Quality System model.
• Support ISO and medical device compliance across operations.
• Promote quality training and 5S in the workplace.
• Collaborate with sales, engineering, and operations to improve processes.

Skills

Quality management systems

Project management

Attention to detail

Verbal and written communication

Organizational skills

Ability to travel up to 15%

Education

Bachelor's degree or equivalent

Job description

Cretex Medical is seeking a Quality Systems Specialist to develop, implement, and maintain the quality management system. The role supports ISO and FDA compliance, leads audits, and drives CAPA programs across the organization.

You will collaborate with quality, operations, engineering, and finance to ensure processes meet customer and regulatory requirements while fostering continuous improvement in a fast-paced environment.