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.
The Quality Management Systems Manager is responsible for the continued effectiveness and compliance of Document Control, Training, CAPA, Internal Audit, External audits and the overall Quality Management System across all Luminex sites.
Key Responsibilities & Duties:
Establishes a highly effective CAPA process, ensuring the disciplined adherence to the procedures that drive the defined workflow and the commitments are met to implement the corrective and preventative actions
Partners with CAPA owners to ensure various CAPA elements (investigations, root cause determination, implementation, and effectiveness) are adequately documented and addressed while ensuring timely completion of all CAPA activities
Establishes an Internal audit process, which enforces compliance with regulatory requirements and identifies areas for improvement
Facilitates the measurement and analysis of data
Implement proactive and preventive strategies for the resolution of quality and compliance opportunities
Assists in the continuous improvement and standardization of quality system procedures and monitors effectiveness
Monitors compliance to state of the art for the quality system and product through implementation of appropriate standards and regulations
Ensures that training on the quality management system is up to date and effective
Education and Experience:
Minimum Bachelor's degree in a scientific or engineering discipline is required
Minimum of 5-7 years in Quality Assurance
Minimum of 5 years in the medical device or equivalent industry
Minimum of 5 years in a manufacturing environment
Experience of conducting formal audits.
Training, Skills and Certifications/Licenses:
Working knowledge of and experience with U.S. FDA Regulations, the Medical Device Directive (98/79/EC) ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulations (CMDR), Brazil ANVISA, Australian MDR and JPAL/GMP
Demonstrated experience in hosting and facilitating audits and regulatory agency inspections with successful outcomes
Demonstrated experience in making decisions to resolve the most complex problems and providing sound compliance advice and direction.
Demonstrated successful interdisciplinary collaboration in a team setting
Strong expertise in continuous improvement methods.
Ability to write clearly and informatively technical documentation, correspondence, procedures and work flows.
Skilled interpersonally; strong communication, negotiation and conflict management skills
Demonstrated proficiency in project management, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation
Must work onsite at Luminex office at least 75-80% of the time
Travel may be required approximately: 20-25% of the time.
International travel may be required approximately 2 % of the time
Work is normally performed in a typical office work environment
Possible exposure to mechanical, biologic and chemical hazards
Frequent use of personal computer, copiers, printers, and telephones
Frequent standing, walking, climbing stairs, 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 of 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, USA