Quality Assurance Technician - Medical Device Manufacturing

Cretex Companies, Inc.; Dassel (MN); On-site; USD 32,000 - 46,000; Full time

Benefits offered by this job

401k with match

Onsite health clinics

Cretex University

Discretionary holiday bonus

Job summary

Cretex Medical in Minnesota is seeking a Quality Engineering Technician to assist Quality Engineers in providing quality assurance support for manufacturing, improving quality related practices and procedures, problem solving, and providing technical guidance and measurement methodologies.

In this role you will develop APQP processes, PFMEA, control plans, Gage R&R studies, IQ/OQ/PQ documentation, and inspection methods for first article through final inspection, while ensuring ISO and

Qualifications

• Associate degree in Engineering or equivalent experience.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Intermediate blueprint reading, GD&T and SPC knowledge.
• Ability to operate a variety of inspection equipment.
• Design software- Minitab.
• MS Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective 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 knowledge

GD&T & SPC

Blueprint reading

Inspection equipment operation

MS Office

Effective communication

Teamwork

Education

Associate degree in Engineering or equivalent experience

Tools

Minitab

Job description

Cretex Medical in Minnesota is seeking a Quality Engineering Technician to assist Quality Engineers in providing quality assurance support for manufacturing, improving quality related practices and procedures, problem solving, and providing technical guidance and measurement methodologies.

In this role you will develop APQP processes, PFMEA, control plans, Gage R&R studies, IQ/OQ/PQ documentation, and inspection methods for first article through final inspection, while ensuring ISO and