Sr. Engineer, Quality

Sr. Engineer, Quality

Department: NC – Quality

Location: Brooklyn Park, MN

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About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!

Position Summary:

The Senior Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements.

Key Responsibilities:

Provide Quality Engineering support for engineering product development, or sustained manufacturing.

Provide Quality Project Management support as needed for product transfers from development to validation to production.

Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.

Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement.

Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.

Must Have:

A Bachelor-s degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.

Experience in an engineering environment with mechanical, tool design, and manufacturing processes.

Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.

Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods, and Procedures; and Supports Innovation.

Good to have:

Medical device experience preferred.

Minitab experience desirable.

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec-s goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.

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