Medical Device - Quality Engineer

Confidential Company  •  Coppell, TX

5 - 7 years experience  •  IT Consulting/Services

Salary depends on experience
Posted on 02/20/18 by Cynet EngineeringTeam
Confidential Company
Coppell, TX
5 - 7 years experience
IT Consulting/Services
Salary depends on experience
Posted on 02/20/18 Cynet EngineeringTeam

We are looking for Medical Device - Quality Engineer for our client in ?????Coppell, TX

 Job Title: Medical Device - Quality Engineer

Job Location: Coppell, TX

Job Description:

  • 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. 

STRATEGY:

  • 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. 

COMPLIANCE: 

  • 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. 

Education:  

  • 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.

Experience:  

  • 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.

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