Diasorin · 6 hours ago
Manager, Post Market Quality Assurance and Audit
Stillwater, MN
Full-time
Onsite
Senior Level
$122K/yr - $145K/yr
7+ years expDiasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. The role serves as the lead for Post Market Quality Assurance and Audit activities, including product Vigilance/Recalls, Post-market Review and Internal/External Audit.
BiotechnologyHealth Diagnostics
Responsibilities
Participate in the Quality Assurance management team to set priorities and policy for the team to ensure support of the organization
Administer and maintain the Vigilance and Recall quality assurance process at Diasorin Inc
Monitor the suitability and effectiveness of the Quality System and ensure compliance with current US and international regulations, ISO 13485 /ISO 9001 standards and IVDR through Internal Audit and other activities. Responsible for Norms management within Diasorin Inc. and updates related to evolving regulatory requirements
Lead external audits by regulatory authorities, notified bodies, customers, etc. Serve as an audit host and organize the audit process
Support post-market activities through review of complaint files and complaint investigations for compliance as well as product-specific post-market reviews
Report on Quality Assurance KPI and outcomes in meetings from team level to corporate level. Responsible for weekly surveillance reporting at corporate level
This team supports Change Management with Quality Systems team and provides backup support to Document systems / Batch release
Direct continuous improvement of our processes to meet the evolving expectations of customers, business partners and regulators
Provide leadership to the team, ensuring clear and aligned objectives, supporting employee development, and encouraging collaboration across the organization
May act as Person Responsible for Regulatory Compliance (PRRC) and as designee for the following as detailed in Article 15 of the EU IVDR 2017/746: Ensure that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; Ensure that the post-market surveillance obligations are complied with in accordance with Article 10(9).; Ensure that the reporting obligations referred to in Articles 82 to 86 are fulfilled; Ensure that in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, statement referred to in the EC Regulation 2017/746 Section 4.1 of Annex XIV is issued
Qualification
Required
Bachelor's Degree Sciences, Engineering, Quality Management or Quality Assurance
7+ Years Experience within quality, regulatory, compliance manufacturing, operations and/or engineering within the Medical Device, Pharmaceutical or Diagnostics industry
Experience with direct contact with FDA and ISO Notified Bodies in audit settings
Knowledge of FDA regulations, ISO 13485, Health Canada regulations, IVDR and other national and international regulations and standards
Strong knowledge of Recall / Medical Device Vigilance activities and requirements as well as complaint handling
Strong skills in internal and external audit, ability to host external audits
Strong leadership, project management skills and ability to influence others in a matrix environment
Strong analytical skills, exceptional writing and interpersonal relationship skills
Demonstrated organizational, management and communication skills
5+ Years People management experience
Strong understanding of immunoassay principles
Preferred
Master's Degree MS in Sciences, Engineering, Quality Management or Quality Assurance
Benefits
A comprehensive plan of health benefits
Retirement and financial wellbeing
Time off programs
Wellbeing support and perks
Annual incentive program
Company
Diasorin
DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics
1001-5000 employees
H1B Sponsorship
Diasorin has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Doug Schuenke
CFO and VP Finance
Davide Marietta
Corporate CIO
Recent News
2026-01-23
2025-12-29
Company data provided by crunchbase