Quality Assurance/Engineering

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Interrad Medical, Inc. is a medical device company located in Plymouth, Minnesota. The company designs, develops and manufactures minimally invasive vascular access implantable medical devices. The Quality Engineer at Interrad Medical fulfills a multi-functional role. The Quality Engineer reports to the Quality Assurance Manager and provides Quality Assurance support to Manufacturing, Operations and Engineering. This job is full-time, on-site in Plymouth, MN.

Primary Job Functions Identify opportunities and coordinate company-wide efforts to maintain and continuously improve the Quality Management System for Interrad Medical to ensure the quality of SecurAcath and other medical devices and components.

Ensure that medical devices manufactured by Interrad Medical are produced in accordance with the requirements of 21 CFR Part 820, ISO 13485, EU MDR and other applicable regulations and standards.

Coordinate the inspection of all materials and products that are purchased by Interrad Medical.

Support the investigation and implementation of any non-conforming material reports or deviations.

Conduct test methods and inspection methods to assist non-conforming material reports, risk assessments and any applicable function of the business.

Initiate and facilitate customer complaint investigations including reportability assessments for vigilance reporting purposes.

Communicate with distributor representatives and customers regarding quality related topics, including investigation findings.

Provide feedback and work with outside vendors and contractors providing products or services to company with regard to quality issues. Work closely to ensure vendor issues are appropriately investigated, resolved, and documented.

Identify issues and recommend solutions for improving product quality and quality systems.

Review, analyze, and summarize results from incoming inspection and manufacturing with regards to yields, scrap, trending and lot release testing.

Includes Medical Device Single Audit Program (MDSAP)

Reviews and approves manufacturing records.

Cross-functional collaboration with engineering and operations on test methods, manufacturing practices and implementation of improvements to the associated processes.

Education Requirements BS degree, Engineering or Life Sciences preferred

Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Knowledge and experience of the interaction between product design and performance, relating design concepts and predicting design output outcomes

Preferred Skills, Experience, and Education 2+ Years medical device or pharmaceutical manufacturing Quality Assurance Experience

Engineering experience and demonstrated use of Quality tools/methodologies

Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

Comprehensive benefits package, including employer-subsidized health insurance with FSA and HSA options, and a 401k retirement plan that allows immediate participation.

Seniority level Entry level

Employment type Full-time

Job function Engineering and Information Technology

Industries Medical Equipment Manufacturing

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