Senior Quality Engineer

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

The Sr QA Engineer will be responsible for tasks related to on-going quality programs; quality System development and implementation validations and process development design change corrective and preventive action change control and quality audits to ensure that assigned Luminex products meet established specifications design criteria and control quality and regulatory standards and customer requirements. The Senior Quality Engineer will trend quality data evaluate risk and make proposals for continuous improvement. The Senior Quality Assurance Engineer is a leader and a mentor.

Job Tasks and Responsibilities

Education Expereince and Qualifications

• Bachelors Degree required. Preferred degree field in an Engineering or life sciences discipline such as Mechanical Electrical Industrial Manufacturing Engineering Biochemistry Chemistry Microbiology Biotechnology or Bio-Engineering.
• 5 Years related experience in IVD medical pharmaceutical or other related industry. required
• 3 Years Experience with risk management corrective & preventative action and change control
• Knowledge of cGMP regulations (21 CFR 820 ISO 13485)
• Must have a thorough understanding of statistical analysis statistical process control Investigation and Root Cause Analysis Corrective and Preventive Action Process and their application to development and manufacturing processes as a problem identification and resolution tool.
• Proficient in Quality Analysis Tools (Taguchi Fishbone) & DOE.
• FDA Product and Process Validation Techniques.

Licenses and Certifications

• ASQ Certified Quality Engineer. preferred
• Certified Quality or Biomedical Auditor preferred

Standard Physical Demands

• Specific vision requirements involve close vision distance vision color vision peripheral vision depth perception and the ability to adjust focus - Occasionally

Standard Working Conditions

• exposed to moving mechanical parts fumes or airborne particles and toxic or caustic chemicals - Occasionally

The range for this position is $86500/year to $156600 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.