New

Senior Quality Engineer

DiaSorin

United States, Minnesota, Stillwater

1951 Northwestern Avenue (Show on map)

Apr 17, 2025

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, we've 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 that's 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 you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're 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 that's 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 a critical member of the Product Quality Assurance team, serving as a subject matter expert regarding Product Quality Assurance and the regulatory requirements of design control for New Product Development. The incumbent is responsible for supporting product quality in manufacturing operations, risk management, change control, validations, nonconformances, and CAPA to ensure high quality records and results that improve products, services and processes. This role will serve as a consultant for internal customers regarding best quality practices, ensuring all Product Quality related activities are performed in a compliant manner to support business objectives.

In a fast-paced, high growth and dynamic environment, this position will be key in supporting the Quality Assurance team to achieve their business unit goals. The ideal candidate will be comfortable interfacing with multi-disciplined teams at all levels to provide quality leadership and facilitate organizational change.

Job Roles and Responsibilities

Nonconformance (NC) system: review issues, recommend CAPA, review/approve nonconformance evaluation reports, monitor efficacy through key NC process metrics, and close NCs within suggested timeframe.
Support the CAPA system by participating in cross-functional CAPA teams, contributing to investigations, owning CAPA when appropriate and performing effectiveness checks as needed.
Review/approve Out of Specification (OOS) records.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues

Lead the relationship with clinicians, owning the organization's risk management program. Support updates and changes to risk files and interface with consulting clinicians.

Ensure that appropriate procedures are established to support Product Development, Product Design Transfer and Manufacturing processes.

Serve as Quality Representative Core Team member for Product Development projects. This includes the creation of the Risk Management File and Design History File for new products, reviewing design and development processes, ensuring appropriate documentation is established in accordance with Design Control procedures.
Review and approve product shelf life extensions.

Review and approve manufacturing and product development validation activities to ensure that they are well established, risk based and compliant with applicable regulations.
Collaborate with Critical Raw Materials, Manufacturing and Product Development personnel to ensure any all changes are appropriately assessed for risk and impact to product, then validated accordingly.
Review and approve equipment qualification protocols and reports and process/product validation protocols and reports.
Ensure that software lifecycle and validation requirements are met and are compliant with the regulations, including software developed for Diasorin.

Gather, analyze, and report data reflecting status of product and process and provide recommendations to improve such activities.

Participate in inspection/audits and assist in external audits.
Perform internal audits as Lead Auditor or as a member of the Audit Team.

Provide consulting support and advisement to internal and external customers of the Diasorin Quality Assurance department.

Provide QA representation and quality engineering support within cross-functional teams relating to:
- Risk Management
- Design Control
- Nonconforming product
- CAPA
- OOS's
- Validation
- Change management
- Continual improvement of the QMS and product quality
- Corporate and local quality plans / projects

Use statistical tools to analyze data to make acceptance decisions and improve processes and product quality.
Gather, analyze and report data reflecting status of product and process and provide recommendations for improvements.

Education, Experience and Qualifications

Bachelor's degree in Engineering, Life Sciences, Chemistry, Physics or related field required.

5+ years of Quality Engineering or Quality Assurance experience in IVD, medical device or other regulated industry

Expertise in the following disciplines:
- FDA QSR, ISO 13485, 9001, 14971 and MDSAP Compliance
- Risk Management
- Design and Process Risk Assessment
- Nonconformance Process
- CAPA and root cause analysis
- Quality Auditing
- Document and Change Control
- Validation methodology
- Statistical methods (process capability, hypothesis testing, regression/correlation, SPC, DOE)
- Familiar with quality tools and problem-solving techniques

Experience with the following preferred:
- Immunoassay
- Six Sigma methodology
- IVDR, MDR, IVDD

ASQ-CQE or other ASQ certification is highly desired.

Well-developed written and verbal communication skills

Good analytical, decision making and problem-solving skills

Ability to function independently, cooperatively and collaboratively in a team environment

Computer skills and software knowledge - MS Word, PPT and Excel
Problem Solving Certification (Green Belt, CQE, Six Sigma, etc.) preferred

The posting range for this position is $82,994 - $110,166. 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 hrtalent@diasorin.com or 1-800-328-1482 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.