We envision a Luminex solution in every lab around the world seeking to obtain timely and confident answers. We aim to lead with transformative solutions that uniquely accelerate reliable answers while reducing the overall cost of advancing health.
Luminex is a growing company that offers great benefits and the opportunity to learn alongside talented individuals. Come join our team as a Sr. Quality Assurance Engineer (Sr. QA Engineer). The selected candidate will be responsible for the following:
Providingleadership for the design, creation, implementation and monitoring of programsand methodologies to ensure that Luminex products and systems meet establishedspecifications, design criteria, quality standards and customer requirements.
Leadinginternal/external audits and continuous improvement efforts.
Servingas a subject matter expert.
Providingsustaining and design control quality support for on-market products.
Developingand provides leadership for Quality Systems processes globally.
Key Responsibilities & Duties:
Evaluatesdeviations, non-conformances, customer complaints and process/product changecontrol for completeness and impact on quality for on-market products
Reviews,consults and approves Risk Analysis
Serves asQuality representative and provides leadership on product development teamsresponsible for Design Control requirements
Providesleadership and guidance for developing equipment/product/process Verification& Validation Protocols, such as IQ, OQ, PQ
Reviewrecords for product release and documents for completeness & accuracy undera production schedule
Developsand implements global quality system documentation
Identifieskey performance metrics and develops reporting mechanism
Preparesand presents material at executive level meetings
Identifies,investigates and leads other departments to resolve quality issues
Leadsinternal and supplier compliance audits to established Quality System Manualand applicable regulations and standards
Supportssupplier quality activities
Leadscontinuous improvement opportunities and works globally to implementcorrective/preventive actions and improvements
LeadsQuality System training and participates in the development of trainingprograms regarding all aspects of quality
Acts as aglobal expert for quality related questions & challenges
Acts asEscort during external audits/inspections
Mentorspersonnel to continuously enhance the company's quality culture
Leads,and assures successful implementation, special projects as directed
Acts as apoint of contact for external customers
Education and Experience:
Bachelor degree required in a life science or engineering discipline preferred
Experiencein an Good Manufacturing Practices (GMP) environment required, preferably inmedical device industry
Expertknowledge of current industry quality practices under QSRs, CMDR, IVDD &ISO-13485
Experiencewith conducting internal & supplier audits preferred
Minimum 8years' experience in regulated environment, previous Quality experiencepreferred
Experiencewith corrective & preventive action is preferred
Experience with change control is preferred
Experiencewith internal auditing and supplier qualification and auditing is preferred
Training, Skills and Certifications/Licenses:
Excellent interpersonal, verbal and written communication skills
Certification in a quality discipline preferred, such as CQM, CQA, CQE, etc.
Familiarity in statistical tools for acceptance criteria and sample size determination
High degree of problem solving and analytical skills
Strong organizational and time-management skills
Demonstrated ability to lead successful teams
Travel (10%; limited international travel)
Possibleexposure to mechanical, biologic and chemical hazards
PhysicalDemands: All positions require standing, stooping, bending, climbing, sitting,kneeling, and lifting at least 10 lbs.
Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.
Job Family US
Pay Type Salary
Austin, TX 78727, USA