Quality Systems Engineer: ISO/FDA Compliance & Audits

Cretex Medical Component and Device Technologies; Brooklyn Park (MN); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Discretionary holiday bonus program

Cretex University

Employee assistance program

Wellness program

Life insurance benefits

Paid time off

Job summary

Cretex Medical, a leading contract manufacturer for medical devices, seeks a Quality Systems Engineer to support enterprise-level QMS processes, CAPA, audits, and regulatory training. You will facilitate and administer core quality activities across ISO 9001, ISO 13485, and FDA QSR compliance, and contribute to data-driven improvements.

The role requires a Bachelor’s in a STEM field and 5+ years in regulated environments, with strong BI, MS Office skills, and travel up to 15%.

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Programming, or related STEM field.
• 5+ years of experience with quality management systems in regulated environments (ISO 13485, EU MDR, FDA).
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Academic experience with business intelligence software tools.
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint, Publisher).
• Strong verbal and written communication skills.
• Attention to detail and organizational skills.
• Ability to work in a fast-paced team environment and multitask.
• Willingness to travel up to 15%.

Responsibilities

• Identify, develop, and maintain QMS programs to promote quality awareness and ensure compliance with policies and procedures.
• Lead internal, external and supplier audits, including preparation, execution, reporting and follow-up.
• Manage the internal audit program and corrective actions.
• Assist in defining and improving QMS processes to meet ISO 9001, ISO 13485, and FDA QSR.
• Participate in internal audits for ISO 9001/13485 and FDA QSR.
• Write and revise procedures and policies within the quality system scope.
• Analyze data to identify improvement opportunities and support CAPA activities.
• Support BI reporting, enterprise workflows, and quality-system automation.

Skills

Quality management knowledge

Regulatory requirements

Communication skills

Organizational skills

Attention to detail

Team collaboration

Multitasking

Travel readiness

Education

Bachelor’s degree in CS/SE or STEM

Tools

Microsoft Office

Business intelligence tools

Job description

Cretex Medical, a leading contract manufacturer for medical devices, seeks a Quality Systems Engineer to support enterprise-level QMS processes, CAPA, audits, and regulatory training. You will facilitate and administer core quality activities across ISO 9001, ISO 13485, and FDA QSR compliance, and contribute to data-driven improvements.

The role requires a Bachelor’s in a STEM field and 5+ years in regulated environments, with strong BI, MS Office skills, and travel up to 15%.