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:

You will be responsible for onboarding new suppliers, maintaining and updating supplier files, and managing the Cirtec Approved Supplier List. Your duties will include conducting supplier audits, processing supplied material nonconformances, processing supplier change requests, issuing and managing Supplier Corrective Action Requests (SCARs), and driving continuous improvement initiatives with suppliers. You will work closely with suppliers to ensure compliance with regulatory and quality requirements, enhance purchasing controls, and support the qualification of supplied components. This role requires strong collaboration with internal teams and suppliers to mitigate risks, improve supplier performance, and uphold Cirtec’s commitment to delivering high-quality medical devices

Key Responsibilities:

Tracks supplier responses and conducts follow-up and escalation as necessary. Reviews current Quality Agreements and determines the need to revise. Solicits revised Quality Agreements as determined. Obtains and analyzes performance and quality indications information from internal sources for each supplier. Prepares and submits required quality records and documents for closure and filing. Manages the development of supplied product inspection procedures and first article requirements. Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits. Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions. Participates and provides engineering ownership for all supplies product Non-Conforming Material Reviews.

This is an onsite role

Must Have:

Bachelors degree in engineering or STEM equivalent plus 2 years of experience in quality engineering. Experience in an engineering environment with mechanical, tool design, and manufacturing processes. Experience with CAPAs, process validation, design controls, and risk management. Ability to read and understand prints including GDT. Proficient in English Ability to travel to the US (American Visa

Good to have:

Medical device knowledge

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.