Quality Engineering Tech - Medical Devices | APQP & CAPA

Regulatory Jobs; Dassel (MN); On-site; USD 32,000 - 45,000; Full time

Benefits offered by this job

401k retirement plan

Onsite health clinics

Paid holidays

Cretex University

Employee assistance program

Job summary

Cretex Medical is a leading contract manufacturer for the medical device industry. The Quality Engineering Technician will assist Quality Engineers, support APQP, PFMEA, control plans, and CAPA processes, while performing routine floor inspections and upholding ISO and medical device standards.

We value collaborative teamwork across sales, engineering, and quality, with strong attention to detail and hands-on use of inspection equipment in a fast-paced manufacturing environment.

Qualifications

• Associate degree in Engineering or equivalent experience.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Blueprint reading, GD&T and SPC knowledge.
• Ability to operate a variety of inspection equipment.
• Design software—Minitab.
• Cross-train in other areas of production when required.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear verbal and written communication skills.
• Attention to detail.
• Organizational skills.
• Ability to work in a fast-paced team environment.
• Ability to prioritize and multitask.

Responsibilities

• Partner in the development of the APQP process and project management.
• Assist in the development of PFMEA.
• Support the development and implementation of control plans.
• Assist in the development and implementation of Gage R&R and capability studies.
• Support the implementation of IQ, OQ, PQ documentation.
• Assist in the development, implementation, and maintenance of inspection methods for first article, receiving, in-process, and final inspection.
• Design inspection fixturing and gaging.
• Assist the investigation, root cause analysis, and corrective action activities to support the CAPA and Customer Complaint systems.
• Perform routine inspection activities on the floor.
• Support and comply with the company Quality System, ISO, and medical device requirements.
• Read, understand, and follow work instructions and standard work.
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance.
• Understand customer needs and the core business markets we serve.

Skills

Quality systems

GD&T

SPC

Blueprint reading

Measurement equipment

Minitab

MS Office

Communication

Organizational skills

Team collaboration

Education

Associate degree in Engineering or equivalent experience

Tools

Inspection equipment

Minitab software

Job description

Cretex Medical is a leading contract manufacturer for the medical device industry. The Quality Engineering Technician will assist Quality Engineers, support APQP, PFMEA, control plans, and CAPA processes, while performing routine floor inspections and upholding ISO and medical device standards.

We value collaborative teamwork across sales, engineering, and quality, with strong attention to detail and hands-on use of inspection equipment in a fast-paced manufacturing environment.