Quality Assurance Engineer, Medical Device

At Precision Medical, Inc., we are driven by a clear and unwavering mission: to make people's lives better. We achieve this by our deep commitment to create life-enhancing respiratory solutions through products and services that you can depend on. As a global leader in medical device manufacturing, we specialize in the design and production of precision-engineered respiratory equipment. From cutting-edge oxygen, air, and suction systems for healthcare facilities to at-home solutions like air compressors and aspirators, we develop products that empower both healthcare providers and patients.

We are a family-owned and operated company with a legacy of quality, innovation, and care that spans more than four decades. We measure success not only by our business growth but by the meaningful impact we have on the lives we touch—whether through improving patient care, supporting medical professionals, or fostering healthier communities.

Precision Medical is seeking a Quality Assurance Engineer, Medical Device to work on site at our facility in Northampton, PA.

Job Summary:

The Quality Assurance Engineer, Medical Device will act as a liaison between Quality and Engineering to ensure products meet or exceed safety, efficacy and reliability standards.

Duties/Responsibilities:

· Create/update Risk Management files in compliance with ISO 14971:2019.

· Create and maintain Medical Device files/Technical files.

· Review literature and labels.

· Create/revise Quality documentation.

· Develop/control Quality Assurance databases.

· Investigate complaints and coordinate recalls as assigned.

· Maintain Material Safety Data Sheets.

· Conduct analysis of data reports.

· Perform any additional requested task necessary to ensure the successful operation of the company.

Required Skills/Abilities:

· Excellent verbal and written communication skills.

· Strong organizational skills and attention to detail.

· Excellent time management skills with a proven ability to meet deadlines.

· Proficient with Microsoft Office Suite.

Education and Experience:

Bachelor’s degree in a science/engineering/health or other related field, or 3-5 years of experience in medical device industry.

Previous experience with ISO 13485:2016 required.

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer; ability to alternate between sitting, standing and walking as needed.

Precision Medical, Inc. is an equal opportunity employer.

Precision Medical, Inc. does not accept unsolicited resumes from search firms for this employment opportunity.

Pay: $65,000.00 - $71,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person