What are the responsibilities and job description for the Senior Quality Engineer position at Diasorin?
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?
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
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
Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA)
Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, Process, off-the-shelf software, etc.)
Review, consult, and approve design change activities
Evaluate deviations, non-conformances, out of specifications, customer complaints and process change controls for completeness and impact on product quality
Review, consult, and approve risk analysis
Conduct or serve as a lead/coordinator of investigations for corrective and preventive action (CAPA)
Prepare and trend data/materials for meetings and present
Participate in audits and inspections
Participate in various review boards as required, example Supplier Review board, Material Review board
Collaborate with operations on the implementation of process controls and improvements
Write and/or implement changes to controlled documents as needed.
Investigate and collaborate with other departments to resolve quality issues
Provide day-to-day guidance and training to other QA personnel, as required.
Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products.
Provide day-to-day support for manufacturing to resolve any quality issues.
Leader in Quality system continuous improvement activities
Mentors personnel to continuously enhance the company’s quality culture
Support and participate in other QA related activities as required
Education, Expereince And Qualifications
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.
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.
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
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
Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA)
Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, Process, off-the-shelf software, etc.)
Review, consult, and approve design change activities
Evaluate deviations, non-conformances, out of specifications, customer complaints and process change controls for completeness and impact on product quality
Review, consult, and approve risk analysis
Conduct or serve as a lead/coordinator of investigations for corrective and preventive action (CAPA)
Prepare and trend data/materials for meetings and present
Participate in audits and inspections
Participate in various review boards as required, example Supplier Review board, Material Review board
Collaborate with operations on the implementation of process controls and improvements
Write and/or implement changes to controlled documents as needed.
Investigate and collaborate with other departments to resolve quality issues
Provide day-to-day guidance and training to other QA personnel, as required.
Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products.
Provide day-to-day support for manufacturing to resolve any quality issues.
Leader in Quality system continuous improvement activities
Mentors personnel to continuously enhance the company’s quality culture
Support and participate in other QA related activities as required
Education, Expereince And Qualifications
- Bachelor's 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.
- ASQ Certified Quality Engineer. preferred
- Certified Quality or Biomedical Auditor preferred
- Specific vision requirements involve close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus - Occasionally
- exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals - Occasionally
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.
Salary : $86,500 - $156,600