Senior Quality Assurance Engineer (6928)
Senior Quality Assurance Engineer (6928)
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1 Vacancy
Job Description
Diasorin is a global leader in diagnostic solutions pushing the boundaries of science and technology to create cuttingedge 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 SUMMARY
The Sr QA Engineer will be responsible for tasks related to ongoing 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.
Key Responsibilities and Duties
- 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 offtheshelf software etc.)
- Review consult and approve design change activities
- Evaluate deviations nonconformances 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 daytoday 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.
- Review records and data for product release.
- Leader in Quality system continuous improvement activities
- Quality Representative in new Product Development core teams
- Mentors personnel to continuously enhance the companys quality culture
- Support and participate in other QA related activities as required
QUALIFICATIONS
- Bachelors degree required with a life science or engineering discipline preference
- 5 years Experience in Quality Assurance role Required
- 3 Years Experience with risk management corrective & preventative action and change control Required 3 Years Knowledge of cGMP regulations (21 CFR 820 ISO 13485) Preferred
- 3 Years Working knowledge of statistics trending and root cause analysis Preferred
- 2 Years Experience in an Operations support role
- Certification in a quality discipline preferred such as CQE CQA CQM
- Excellent interpersonal verbal and written communication skills
- Strong skills and knowledge of corporate software tools Microsoft Office Suite including
- Word Excel Access and Power Point.
- High degree of problem solving attention to detail and analytical skills.
- Strong organizational and timemanagement skills.
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 orto 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 preemployment background check and drug screen subject to applicable laws and regulations.
This position is not eligible for partnership with a thirdparty search firm vendor without expressed written consent from the Diasorin Human Resources Department.
Required Experience:
Senior IC
Employment Type
Full-Time
