QA Technician I

Minnetronix, Inc.; Minnesota; On-site; USD 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Final Release Quality Assurance Technician to join their team. In this role, you will conduct final inspections of medical device documentation, ensuring accuracy and compliance with traceability requirements. You will collaborate closely with engineers and shipping teams, contributing to the quality assurance process in a fast-paced environment. This position offers a unique opportunity to work alongside innovative medical device companies, making a significant impact in the healthcare sector. If you are detail-oriented and passionate about quality assurance, this role is perfect for you.

Qualifications

• 2 to 3 years’ experience in inspection or documentation review preferred.
• Proficiency in Good Documentation Practices (GDP) is essential.

Responsibilities

• Review Device History Records for completeness and accuracy.
• Interact with Engineers and Technicians regarding DHR items.

Skills

Good Documentation Practices (GDP)

Detail-oriented

Organizational Skills

Communication Skills

Microsoft Office Products

Education

Experience in inspection or documentation review

Relevant education in manufacturing

Tools

System applications for documentation

Job description

Minnetronix Medical, St. Paul, Minnesota, United States of America

Job Description

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Minnetronix Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary:

Final Release Quality Assurance Technicians conduct final inspection of medical device traceability documentation, create Finished Goods documentation, and support other Device History Record (DHR) activities as requested.

Job Duties and Responsibilities:

• Review Device History Records (DHRs) for completeness, legibility, and accuracy.
• Interact with Engineers, Technicians, and Assemblers regarding DHR items.
• Communicate closely with Shipping team members.
• Upload documentation to system applications and physical organization of documentation.
• Collect or monitor data as requested by Engineers.

Qualifications:

• 2 to 3 years’ experience working in inspection, documentation review, in a manufacturing environment, or relevant education is preferred.
• Proficiency in Good Documentation Practices (GDP).
• Familiarity with Medical Device traceability requirements and best practices.
• Organized, detail oriented, and possess good written and oral skills.
• Ability to prioritize tasks and adapt in a fast-paced environment.
• Working knowledge of Microsoft Office Products and computer literate.

Working Conditions:

• Will be expected to handle items that may weight up to thirty (30) pounds.
• Must be authorized to work in the United States.

EEO Statement

Minnetronix, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Unity

We work hard and work together towards a common goal.
We put aside narrow interests to pursue the best outcomes for the company.

Humility

We aspire to collective excellence and know the sum is greater than the parts.
We own our successes and our failures and believe in growth through self-improvement.

Courage

We listen, learn and know when to make tough decisions.
We step up and step in, always.
We move out of our comfort zone in order to do what’s right and not just what’s easy.
We lead change effectively, operate with integrity and hold ourselves accountable.

Drive

We are driven to improve life for patients.
We relentlessly create and deliver value for our customers.
We constantly challenge ourselves to improve our thinking and our doing.

EEO Statement

Minnetronix, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Minnetronix Medical, St. Paul, Minnesota, United States of America