Manager, Post Market Quality Assurance and Audit

Diasorin is a global leader in diagnostic solutions pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years weve earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions made available thanks to ongoing investments in research positions us as the player with the widest range of specialty solutions in the sector and identifies us as the Diagnostics Specialist.

Why Join Diasorin

• Impactful Work: When you join Diasorin you become part of a team thats dedicated to improving lives. Your contributions will directly impact patient care making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world expanding your horizons and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive collaborative environment where everyone can thrive.

Join Our Team: If youre passionate about innovation diversity and making a positive impact on healthcare Diasorin is the place for you. Were looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team thats shaping the future of diagnostics Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier more connected world. Together we can make an impact!

Job Scope

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

Key Responsibilities and Duties

• 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.

Additional Responsibilities and Duties

• 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.

Education Experience and Qualifications

• Bachelors Degree Sciences Engineering Quality Management or Quality Assurance or
• Masters 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

Training and Skills

• Strong understanding of immunoassay principles

Travel

• 10% periodically domestic travel

The salary range for this position is 122000 - 145000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including but not limited to educations skills work experience certifications etc. Beyond base salary 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. Benefits may vary by role country region union status and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award if any depends on various factors including individual and organizational performance.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.

In compliance with federal law all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process please contact the North America Talent Acquisition Team at or 1- to request an accommodation.

The above job description is intended to describe the general content identify the essential functions and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties responsibilities or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed written consent from the Diasorin Human Resources Department.