Quality Engineer, CAPA (St Jude Medical, Plano TX)
Facilitate, lead, communicate and support corrective and preventive action activities ensuring that all internal operating procedures are complied with and the defined requirements are met. Provide guidance to CAPA owners and teams through all corrective and preventive action steps including problem definition, scope, root cause analysis/investigation, risk assessment, containment, corrective action planning, verification/validation, implementation and effectiveness review. Promote an atmosphere of quality achievement through a successful corrective and preventive action program.
Major, On-Going Responsibilities:
o Lead CAPA activities by facilitating CAPA owners and teams to meet the defined internal procedures and ensure the CAPA program remains compliant with defined requirements.
o Administer daily corrective and preventive activities:
o Review and assess all corrective action requests
o Monitor open CAPA records and ensure activities are completed accurately and are timely
o Compile CAPA requests, plans and closures and ensure readiness for weekly CAPA Board review
o Track and monitor all CAPA Board Action Items and report progress in weekly CAPA Board reviews
o Closely monitor and drive root cause analysis and investigation methodology throughout process.
o Ensure timeliness throughout each phase of the CAPA process by communicating with CAPA owners and teams and verifying CAPA records are being updated adequately throughout the process.
o Assist in compiling CAPA metrics for required periodic monitoring and trending.
Experience & Training:
· 3+ yrs relevant work experience
· Minimum 3 years experience in a medical device or pharmaceutical industry.
· Minimum 1 years experience with CAPA systems.
· Minimum 1 years experience applying regulations (including FDA and ISO13485)
· Familiarity with continuous improvement methodologies, including lean management
· Ability to work independently in fast-paced environment with little supervision
· Ability to identify root cause and creatively problem solve to achieve effective resolution
· Ability to analyze problems, work independently as well as in a team environment, and organize and execute multiple work tasks simultaneously.
· Ability to communicate effectively (both written and oral)
· Team-oriented and responsive to customer needs
· Strong problem solving and analytical skills
· Quality focused, attentive to detail and results oriented
· Ability to influence positive change effectively
· Ability to build strong relationships
· Six Sigma Black Belt Certification a plus
· Proficient with software programs to facilitate data analysis work; must be proficient in MS Office (Microsoft Work, Excel, PowerPoint, Outlook)
· Excellent communication skills, including written, verbal and interpersonal
· Good conflict-management skills.
· Ability to learn quickly and multi-task.
· Self-motivated and able to work independently as well as in a team-environment.
· Strong attention to detail
· Influencing – champion initiatives that generate organization-wide understanding and support
· Problem Solving – establish resources, processes to gather information/data for problem solving or analysis
· Decisiveness and judgment based on data and sound reasoning