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QA Engineer

4 months ago

Austin, Texas, United States DiaSorin Full time
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

TheQA Engineerwill participate in the design, creation, implementation and monitoring of programs and methodologies to ensure that assigned Luminex products meet established specifications, design criteria and control, quality and regulatory standards and customer requirements. QA Engineer provides sustaining and design control quality support for on-market products and products under development. QA Engineer develops and provides leadership for Quality System processes.

Key Duties and Responsibilities

  • Evaluate deviations, non-conformances, customer complaints and process/product change control for completeness and impact on quality for on-market products
  • Review, consult and approve Risk Analysis
  • Serve as Quality representative on product development teams responsible for Design Control requirements
  • Provide leadership and guidance for developing equipment/product/process Verification & Validation Protocols
  • Review records for product release and documents for completeness & accuracy under a production schedule
  • Identify key performance metrics and develops reporting mechanism
  • Prepare and presents material at meetings
  • Identify, investigate and collaborate with other departments to resolve quality issues
  • Lead continuous improvement opportunities and works cross-functionally to implement corrective/preventive actions
  • Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products
  • Serve as a resource within and cross departmental for quality related questions & challenges
  • Support audits and inspections
  • Support and participate in other QA related activities as required
  • Other duties as assigned

Education, Experience, and Qualifications

  • Bachelor's Degree required with a life science or engineering discipline required
  • 5+ Years Experience in a Quality Assurance, Engineering, or Scientist role required
  • 5+ Years Experience with change control & complex problem solving required
  • 3+ Years Knowledge of cGMP regulations (21 CFR 820, ISO preferred
  • Knowledge of cGMP regulations (21 CFR 820, ISO preferred
  • Certification in a quality discipline preferred, such as CQM, CQA, CQE
  • Computer skills (Microsoft Windows and Office programs), familiarity with Oracle, preferred
  • Demonstrated problem-solving and analytical skills
  • Verbal and written communication skills (High proficiency)
  • Organizational and time-management skills (High proficiency)
  • Certification in a quality discipline preferred, such as CQM, CQA, CQE preferred

Working Conditions Physical Demands, Travel, etc.

  • Must work onsite at Luminex office at least 90% of the time - Frequently
  • Work is normally performed in a typical office work environment - Frequently
  • Possible exposure to mechanical, biologic and chemical hazards - Rarely
  • Frequent use of personal computer, copiers, printers, and telephones - Frequently
  • Frequent work under stress, as a team member, and in direct contact with others - Frequently

What we offer

Receive a competitive salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world.


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 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.

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

This contractor and subcontractor shall abide by the requirements of 41 CFR a), 41 CFR a) and 41 CFR a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. 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.