SENIOR QUALITY ASSURANCE ENGINEER
The Sr. Quality Assurance Engineer will provide ongoing quality engineering (product and process) support throughout the product lifecycle. Additionally, the selected candidate will drive change by establishing, implementing, and improving upon sustainable processes, improving products and providing management with actionable process and product data in order to ensure continuous improvement.
Key Responsibilities & Duties:
• Nonconforming Material, Corrective and preventive Action (CAPA), and Complaints
− Ensures completeness and adequacy of records, including any applicable investigations and corrective actions.
− Ensures any applicable risk analyses performed are complete and comprehensive.
− Conduct or serve as lead/coordinator of investigations for CAPA.
− Review, consult and approve applicable quality records.
− Participates in Material Review Board (MRB) activities as needed.
− 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.)
• Design Controls
− Participates in new Product Development core teams as the Quality Representative.
− Review, consult, and approve design change activities.
• Change Control
− Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
− Review, consult and approve ECOs, deviations, etc.
• Supplier Quality
− Participate and/or leads supplier audits for supplier qualification and quality-related issues related to area assigned as needed.
− Escalates/communicates any identified supplier quality issues to management.
− Provides new employee compliance, Agile, and Oracle training.
− Provides day-to-day guidance and training to other QA personnel, as required.
− Supports Quality system training and participates in the development of training programs regarding all aspects of producing quality products.
• Develop and implement quality systems and procedures.
• Prepares and collects materials for the monthly Reagent CAPA and Reagent Quality Review meetings and quarterly EQR.
• Participates in internal compliance audits to ensure Quality System requirements and any applicable regulations and standards are met (FDA, ISO, CMDR, IVDD).
• Log, file, maintain and archive various QA records.
• Reviews records and data for product release.
• Participates in Quality System continuous improvement activities
• Other duties as assigned.
Education and Experience:
• BS or BA degree, preferably in biological sciences.
• Minimum of 5-8 years of experience in quality assurance (preferably in regulated industry, medical device industry experience highly desirable)
• Working knowledge of current industry quality practices under ISO 13485, CMDR and IVDD Quality System.
• Experience with corrective and preventive actions is preferred.
• Experience with internal auditing and supplier qualification and auditing is preferred.
• Experience implementing process monitoring and controls is preferred.
• Experience with change control is preferred.
Training, Skills and Certifications/Licenses:
• Excellent interpersonal, verbal and written communication skills
• Certification in a quality discipline preferred, such as CQT, CQA, CQM, etc.
• 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.
• Must work onsite at Luminex office
• Travel may be required at least 10% of the time
• Work is normally performed in a typical manufacturing work environment
• Possible exposure to mechanical, biologic and chemical hazards
• Frequent use of personal computer, copiers, printers, and telephones
• Frequent standing, walking, sitting, listening, and talking
• Frequent work under stress, as a team member, and in direct contact with others
• Physical Demands: All positions require standing, stooping, bending, climbing, sitting, kneeling, and lifting at least 10 lbs. Additional physical requirements are listed below: o Pounds lifted (up to 20lbs)
o Vision (Color) on the job is required occasionally