Luminex is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team. If changing the diagnostic landscape and revolutionizing patient care sounds like something you would like to be a part of, we invite you to apply today! Together, we can help healthcare providers improve patient outcomes, make a differencein fighting the COVID-19 outbreak, and tackle the world’s most pressing health issues. You can learn more about our values, mission, and vision by visiting our website https://www.luminexcorp.com/about-luminex/.
The Field Quality Assurance Engineer Associate is responsible for participating in Field Quality investigation efforts. This includes data analysis and root-cause investigations, RMA investigations, development of detail Risk profiles for issues, reviewing and collating field quality data to pro-actively identify potential field issues and initiating and supporting recall activities. Note: No relocation assistance provied.
What you will do
- Assists with customer complaint technical investigation, analysis, escalation and closure
- Supports proper review, classification, investigation and closure of customer complaints.
- Assists in the RMA process including investigations and resolutions, identification of removal and corrections which require escalation, RMA metrics development, analysis and action determination
- Initiates complaint investigations, recall investigations, and CAPAs from RMAs and Complaints.
- Assists in the review and approval of RMAs to assess and document removals and corrections.
- Assists recall management. Includes tracking and closure.
- Participtates in Customer Advisory Notificaton (CAN) deployment.
- Collects and analyzes, presents and initiates appropriate action for all field quality data
- Particiates in investigations interfacing with internal groups (QA, Operations, Research and Development, RA, Technical Support and Field Support)
- Prepares presentations for EMR, IQR an RQR providing Field Quality Performance metrics.
- Participates in Audits – internal and external, as SME or escort. Represents the organization in external audits for Field Quality, RMA, Removal and Corrections and Complaint investigation status.
- Understands and applies QMS processes for RMA, Risk Analysis, Complaint Investigations and ensures alignment to necessary governing regulations both domestic an international.
- Responsible for all aspects of regulatory compliance and regulations
- Bachelor’s Degree required, in a life science/engineering discipline preferred required
- 1+ Years Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971, CFR 820 and CFR 806 preferred preferred
- 1+ Years Possesses a strong scientific and technical background, sufficient to establish credibility with senior management as well as the manufacturing and product development teams. preferred
- 1+ Years 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. preferred
- 1+ Years Hands-on ability to sort through technical complexities and work in a flexible changing environment. preferred
Training and Skills
- Excellent interpersonal, verbal and written communication skills (High proficiency)
- Highly organized with proven time management and prioritization skills (High proficiency)
- High degree of problem solving, attention to detail, and analytical skills. (High proficiency)
- Thorough knowledge of standards and regulations (cGMP, ISO 13485) (Low proficiency)
- Certification in a quality discipline preferred, such as CQM, CQA (Low proficiency)
- Experience working independently in a fast-paced environment with rapidly changing priorities (Low proficiency)
- Ability to work independently and with minimal supervision (Medium proficiency)
- 10% Travel may be required
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.