Manager, Post Market Quality Assurance and Audit

Diasorin • Stillwater, MN

30d

About The Position

This role serves as the lead for Post Market Quality Assurance and Audit activities for Diasorin Inc. including product Vigilance/Recalls, Post-market Review and Internal/External Audit.

Requirements

• Bachelor's Degree Sciences, Engineering, Quality Management or Quality Assurance or Master's Degree MS in Sciences, Engineering, Quality Management or Quality Assurance Preferred
• 7+ Years Experience within quality, regulatory, compliance manufacturing, operations and/or engineering within the Medical Device, Pharmaceutical or Diagnostics industry Required
• 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

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.

Benefits

• Diasorin offers a competitive rewards package focused on your overall well-being.
• We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks.
• You may also be eligible to participate in an annual incentive program.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager