Quality Management Systems Manager - Us

Luminex Austin , TX 78719

Posted 3 months ago

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

Work Conditions:

  • 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.

Other details

  • Job Family US

  • Pay Type Salary

  • Austin, TX, USA

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Quality Management Systems Manager - Us