Sr. Post Market Customer Quality Specialist (Hybrid in Minneapolis)

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: Sr. Post Market Customer Quality Specialist

Location: Minneapolis, MN (Hybrid)

A Day in the Life

Responsibilities include the following, other duties may be assigned:

• Responsible for overseeing global complaint handling process and supervise team members.
• Responsible for reviewing complaint report for coding accuracy and reportability decisions.
• Determines Reportability of complaints to Government Agencies and submits reports as needed. Countries requiring reporting include but are not limited to US, EMEA, China, Japan, Brazil & Australia.  Periodic Summary reporting in some geographies may also be required.
• Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
• Drafts responses to regulatory authorities and investigation summaries.
• Technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.
• Participates in data review for Post Market processes (trending/signals, Issue Impact Assessment, etc.)
• Reviews and interprets risk management documentation as it applies to the complaint event. 
• Interacts with multiple departments within Mozarc Medical, such as Investigators, R & D and Engineering.
• Liaison with groups who perform additional investigation and who prepare written record of investigation.
• Participates in audits, directly or indirectly by providing data or documentation and act as Subject Matter Expert as needed.

Must Have:

• Bachelor’s degree and a minimum of 4 years relevant experience or an advanced degree and 2 years of experience

Nice to Have

• 3 + years of previous experience leading a complaint handling team.
• 3+ years experience in Post Market Surveillance/Quality assurance or regulatory experience in medical or pharmaceutical industry.
• Working knowledge of 21 CFR part 820.198 Complaint Handling, 21 CFR part 803 for medical device reporting and EU-MDR; complaint handling processes and reporting requirements.
• Strong working knowledge of global regulatory reporting requirements and associated reporting timelines for US and EMEA. Experience with China, Japan, Brazil & Australia preferred.
• Computer literate with skills in Word, Excel, PowerPoint.
• Strong typing skills and ability to write business documents with minimal supervision.
• Strong verbal and written communication skills and ability to work in a team-oriented environment.
• Ability to multitask.
• Ability to understand the functionality/intended use of medical devices.

• Knowledge of SAP and/or PTC Windchill
• Knowledge of ISO 13485 Quality Management Systems and MDSAP (Medical Device Single Audit Program)
• Working knowledge of Field Corrective Action processes and related activities (21 CFR 806 reporting)
• Familiarity with database trending analysis
• Familiarity with Risk Management (ISO 14971)
  
  
  

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.

Physical Job Requirements 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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.