A Brief Overview
The Field Quality Assurance Engineer is responsible for supporting and facilitating 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: Relocation assistance is not available for this position.
What you will do
- Provides customer complaint technical investigation, analysis, escalation and closure
- Ensures proper review, classification, investigation and closure of customer complaints
- Works in the RMA process including investigations and resolutions, identification of removal and corrections which require escalation, RMA metrics development, analysis and action determination
- From RMA and Complaints initiates recall investigations, complaint investigations and recall investigations. Oversees the approval of RMAs.
- Manages recall management. Includes tracking and closure. Oversees CAN deployment and management
- Collects and analyzes, presents and initiates appropriate action for all field quality data
- Coordinates and participates on required internal 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 internationa.
- Responsible for all aspects of regulatory compliance and regulations
- Bachelor’s Degree Bachelor degree required, in a life science/engineering discipline (i.e. Biology, Mechanical Engineering, Electrical Engineering) and minimum 3 years’ work experience in a regulated / medical device industry required
- 1+ Years Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971, CFR 820 and CFR 806
- 1+ Years Experience in a complex manufacturing or product development role
- 2+ Years 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.
- 2+ Years Possesses a strong scientific and technical background, sufficient to establish credibility with senior management as well as the manufacturing and product development teams.
- 2+ 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.
- 2+ Years Hands-on ability to sort through technical complexities and work in a flexible changing environment.
Training and Skills
- Excellent interpersonal, verbal and written communication skills
- Thorough knowledge of standards and regulations (cGMP, ISO 13485)
- Highly organized with proven time management and prioritization skills
- High degree of problem solving, attention to detail, and analytical skills.
- Certification in a quality discipline preferred, such as CQM, CQA
- Experience working independently in a fast-paced environment with rapidly changing priorities
- Ability to work independently and with minimal supervision
- 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.