Qa Engineer Consultant I

You are responsible for:

• Supporting CAPA activities: assessing complex investigations and corrective actions, reviewing test and other complex performance data, leading complex root cause analysis and quality problem solving

• Facilitate product and process CAPA investigations from issue identification through implementation of solution and effectiveness monitoring

• Support CAPA Owner in all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines

• Support CAPA Owners in the presentation of CAPAs during audits and CAPA Review Board meetings

• Mentor cross functional teams with the implementation of appropriate root cause analysis techniques

• Mentor the analyze of quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.

Experience & Background:

• Bachelors engineering degree, or equivalent experience.
• Remote is acceptable, but only EST time zone.
• ISO 9001
• Working knowledge of appropriate global regulations, requirements, and standards 3-4 ; years of related experience in a medical device or other regulated industry.
• The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes
• The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.
• This contingent role is required in order to deploy PDLM and other PEPF processes in CDS
• The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
• Medical Device documentation and QA planning (2+ yrs and 4+yrs)
• Pharmaceutical, Healthcare's
• 21 CFR