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 Sr. QA Manger will be responsible for:
The Senior Manager, Quality Assurance will lead, establish, implement and maintain quality assurance systems and activities ensuring compliance with domestic and international quality system standards and regulations for commercial medical devices designed, produced and marketed by Luminex.The Senior Manager, Quality Assurance will also provide technical and organizational leadership to Quality Assurance activities, Quality System development and implementation, validations and process development, design change, corrective and preventive action, change control, and quality audits and partner with Manufacturing, Design/Development, Systems Engineering, Quality Control and others across functions to deliver the highest quality products. The Senior QA Manager is a leader and a mentor.
Key Responsibilities & Duties
Manages, leads and mentors Quality Assurance department and personnel
Site Management Representative – liason between staff and top management, assure maintenance and effectiveness of quality system and operation, ensure certification remains intact, escort for external audits
Promotes, mentors and coaches staff for growth
QA lead in Risk Management activities, including responses to complaints and recalls
Quality lead in product development team meetings, technical design reviews, and phase gate design review meetings to ensure quality assurance requirements are met.
Integral member of new product development teams.Responsible for ensuring compliance during the design control and design transfer process
Regularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliant and efficient Quality Assurance processes.
Provides input to the Management Review and Quality Review Board processes and monitors the Quality Management System (QMS), and provides training throughout the organization
Responds to identifiedand potential nonconformities, complaints, deviations, and corrective/preventative actions assigned to Quality Assurance
Participates in Audits – internal and external, as SME or escort
Key member of Review Boards as per Quality processes (e.g., MRB, CRT, ORB, SRB)
Responsible for all aspects of regulatory compliance and regulations
Education and Experience
Bachelor degree required, in a life science/engineering discipline preferred or minimum 8 years’ work experience in a regulated / medical device industry required
Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971 preferred
Management experience in a complex quality assurance/quality systems field
Ability to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance.
Possesses a strong scientific and technical background, sufficient to establish creditability with senior management as well as the manufacturing and product development teams.
Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues.
Hands-on ability to sort through technical complexities and work in a flexible changing environment.
Training, Skills, Certifications/Licenses
Excellent interpersonal, verbal and written communication skills
Thorough knowledge of standards and regulations (cGMP, ISO 13485)
Certification in a quality discipline preferred, such as CQM, CQA
Highly organized with proven time management and prioritization skills
Ability to work independently and with minimal supervision
High degree of problem solving, attention to detail, and analytical skills.
Experience working independently in a fast-paced environment with rapidly changing priorities
Must work onsite at Luminex office at least 90% of the time
Travel may be required approximately: 10% of the time
Work is normally performed in a typical office work environment
Occasional local and international travel may be required
Ability to handle pressure of meeting tight deadlines
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.
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