Medical Device Quality Engineering Technician

Quality Tech Services, LLC; Shakopee (MN); On-site; USD 32,000 - 45,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Holiday bonus program

Cretex University

Employee assistance program

Wellness program with incentives

Employee death benefit

Sick and safe leave

Job summary

Quality Tech Services, LLC (QTS) in Minnesota is seeking a full-time Quality Engineering Technician to support manufacturing quality programs. You will assist Quality Engineers with QA activities, problem solving, CAPA, and measurement methodologies.

The role involves developing quality processes, PFMEA, control plans, Gage R&R, IQ/OQ/PQ documentation, inspection methods, fixturing, and calibration management within a medical device context.

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.
• Microsoft 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.
• Desirable: 5 years of experience in machining or manufacturing.

Responsibilities

• Partner in the development of the quality processes 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.
• Manage calibration of equipment and tooling.
• Support and comply with the company Quality System, ISO, and medical device requirements.
• Read, understand, and follow work instructions and standard work.

Skills

Quality systems

Regulatory standards

Blueprint reading

GD&T

Inspection equipment

Communication skills

Attention to detail

Organizational skills

Multitasking

Teamwork

Education

Associate degree in Engineering

Equivalent experience

Tools

Minitab

MS Office

Job description

Quality Tech Services, LLC (QTS) in Minnesota is seeking a full-time Quality Engineering Technician to support manufacturing quality programs. You will assist Quality Engineers with QA activities, problem solving, CAPA, and measurement methodologies.

The role involves developing quality processes, PFMEA, control plans, Gage R&R, IQ/OQ/PQ documentation, inspection methods, fixturing, and calibration management within a medical device context.