Quality Assurance Engineer

Background

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 first product, the SecurAcath subcutaneous catheter securement device, is currently experiencing rapid growth globally.

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.
• Support and assist in the management of the documentation control system
• 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.
• Facilitate product return and failure analysis.
• Communicate with distributor representatives and customers regarding quality related topics, including investigation findings.
• Maintain calibration and preventative maintenance records, coordinate calibration vendors, and ensure calibrations are consistent and compliant with requirements.
• 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.
• Support vendor audits
• Provide back room support for external audits.
• Includes Medical Device Single Audit Program (MDSAP)
• Reviews and approves manufacturing records.
• Assist in the execution of tasks related to sterilization qualification activities.
• Assist with the Corrective Action and Preventive Action process.
• Cross-functional collaboration with engineering and operations on test methods, manufacturing practices and implementation of improvements to the associated processes.
• Support quarterly management review meetings for the company.
• Other duties and tasks assigned.

Education Requirements:

BS degree, Engineering or Life Sciences preferred

Demonstrated Skills:

• Strong analytical, problem solving and communications skills.
• 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
• Self-motivator with a strong desire for hands-on development
• Ability to work in a team environment

Preferred Skills, Experience, and Education

• 2 Years medical device or pharmaceutical manufacturing Quality Assurance Experience
• Advanced Degree
• 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)
• ASQ CQE or other certifications
• Grand Avenue system experience

Salary range: $60,000 - $90,000, depending on experience and qualifications

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