Quality Engineer II
About Mozarc Medical
At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world’s largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients’ lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.
Position Title: Quality Engineer II
Location: Mirandola (MO)
A Day in the Life
In the Quality group you will:
- Support New Product Development key project, collaborating with geographically spread team
- Communicates primarily and frequently with internal contacts, to share information, status, needs and issues and may have some involvement in cross functional assignments
- Will be responsible for specific activities, parts of the project or processes within the job area
- Have a focus on objectives to meet the goals of project and assignments, and contribute to the completion of project milestones
- Review and approve deliverables (e.g. requirements, protocols, reports) to meet internal/external requirements and overall project quality objectives
- Makes suggestions on enhancements to Design Control activities and continuous improvement of Quality Management System
- May provide guidance and assistance to entry level professionals
You must Have
- Bachelor’s degree in engineering, Science or Technical Field with 2 years of experience in engineering, Medical Device design, verification, validation and/or quality OR master’s degree in engineering, Science or Technical Field with 1 year of experience in engineering, medical device design, verification, validation and/or quality
- Knowledge of quality systems and quality assurance processes and principles, with a focus on verification, standard testing, risk management activities (e.g. ISO 13485, FDA CFR 820.30, ISO 14971, FMEA techniques)
- Good oral and written communication and interpersonal skills, be fluent in English, written and oral
- Ability to work independently with general supervision
- Ability to work in team and good collaboration attitude
- Methodical, critical thinking and analytical approach to resolve issues.
- Adherence to timelines and result-oriented attitude
It will be nice if you will have one or more of these skills:
- Experience working in an Active Medical Device Industry (e.g., FDA-regulated, ISO 13485)
- Working knowledge of standards for Medical Devices (e.g. ISO 13485, IEC 62304, ISO 60601-1 family)
- Working knowledge of software development life cycle for Medical Devices (e.g. IEC 62304)
- Experience with submission of products to FDA
- Knowledge of ticket/defects management tools (e.g. Jira)
- Experience with active dialysis devices
- Audit experience (front room as SME)
- Knowledge of project management techniques
Why Work with Us?
Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life.
It’s essential our team members feel valued, supported and empowered too. That’s why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work – helping you reach your potential and enjoy a career full of life-changing possibilities.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this is the position you were waiting for? Apply here!
Other details
- Job Family QA Engineer
- Job Function Engineering
- Pay Type Salary
- 41037 Mirandola, Province of Modena, Italy