Senior Quality Assurance Engineer

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  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.
  

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  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.
  

JOB SUMMARY

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.

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, offthe-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.
• 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 company's quality culture
• Support and participate in other QA related activities as required

QUALIFICATIONS

• Bachelor's 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 time-management skills.