We are looking for Medical Device - Quality Engineer for our client in ?????Coppell, TX
Job Title: Medical Device - Quality Engineer
Job Location: Coppell, TX
- Implements and executes Quality System programs to ensure effective, consistent and standardized processes to meet regulatory requirements.
- Provides Corrective and Preventive Action (CAPA), nonconformance (NC), and internal audit leadership including system implementation/upgrades, user training, metric reporting and trending, and system administration.
- Performs gap assessments and ensures alignment with the MD sector and J&J enterprise standards.
- Design and implement measures to monitor QS performance and drive improvements.
- Identifies improvement opportunities for Quality, process, and business improvement.
- Works withcontracted services to ensure VAWD and state licensing compliance.
- Acts as on-site Subject Matter Expert (SME) and backroom support during regulatory, third party, and notified bodies inspections/audits.
- Drives innovation within functional area.
- Identifies opportunities to align and improve Quality, process, and cost consistent with business objectives.
- Travels to each MD site (excluding FSL) to provide assistance, project support, and/or audit preparation as needed.
- Collaborates with Pharma & Consumer groups to benchmark best practices.
- Publishes periodic NC, CAPA, and auditreports to drive favorable metrics.
- Reviews NC, CAPA, and audit data with management periodically and escalates issues as appropriate.
- Hosts NC/CAPA/audit meetings with sites to review coming due and overdue items.
- Supports and leads auditinspection readiness activities as needed.
- Provide both technical and process support for the CAPA and NC programs.
- Assists in collecting and inputting metrics data in Metrics Studio for all sites.
- Supports VAWD and state licensing compliance.
- Acts as EtQ Instinct (CAPA, NC, & audit), EtQ Symphony (change control), and TrackWise (change control) administrator.
- Conducts site CAPA Review Board meetings.
- Completes gap assessments for CAPA, NC, risk management, and failure investigation J&J enterprise standards.
- Supports FSL Quality System implementation.
- Adheres to the training process.
- Escalates critical quality issues to management in a timely manner.
- Collects and provides Quality & Compliance data to management for Quality System Management Reviews.
- Assists in the development, review, and approval of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents as needed.
- Assists in new product launches at the distribution center.
- Evaluates overall Compliance risk and recommends and implements corrective actions.
- Performs internal audits at all sites as needed.
- Perform periodic walk-thru?s of facilities to ensure compliance to procedures.
- Other duties, as assigned.
- A minimum of Bachelor?s Degree is required, preferably in an Engineering, Life Science, or related discipline. In the absence of a Bachelor?s Degree, special consideration would be considered for individuals who have related background experience that exceeds 2-4years.
- A minimum of 5-10 years of experience in a highly regulated industry is required. Quality and Compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred.
Knowledge, Skills and Abilities:
- Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required.
- Experience with ERP and Warehouse Management Systems is preferred.
- Experience with Quality Management Systems such as TrackWise and/or EtQ is preferred.
- Proficiency in organizational and project management skills is preferred.
- Experience with Temperature Control is preferred.