favorite this post Supv - QA and Document Control MEDICAL DEVICE 75K!! (Wilmington) hide this posting unhide

260 Fordham Road

(google map)

compensation: 75K annually with bonus potential
employment type: full-time

The desired candidate will have experience working as a “hands-on” Supervisor of Quality and Documentation Control, preferably working in a medical device company. Specific experience and responsibilities will include, but not limited to: supervision of Quality Inspectors and Documentation Control staff; organize and direct workload; create, monitor and report metrics to both team and management; conduct weekly team meetings to discuss projects and enhance communication.
• Provide supervision to QA and Documentation Control staff members
• Conduct weekly QA and Documentation Control team meetings
• Create individual employee goals and monitor performance
• Address performance issues in an encouraging and timely manner
• Ensure all inspections are performed in a timely manner and without issue
• Alert QA Management regarding questionable measurements and/or non-conforming parts
• Review inspection documentation ensuring requirements are met
• Complete NCMR's as required
• Ensure all calibration and measurement tools are in working order
• Monitor and verify that First Article inspections are conducted per customer requirements
• Conduct 1st piece approvals
• Conduct root cause analysis on non-conforming parts
• Create and publish metrics monthly on all QA and Documentation Control projects both in-process as well as completed
• Verify completion and accuracy of inspection records
• Ensure compliance with ISO-13485 and FDA CFR 820 requirements are meet by following GMP, accurate documentation, and reporting
• Assist manufacturing, when required, to ensure that quality products are being produced
• Seek continual improvement with specific suggestions for all inspections
• Perform process-mapping for Document Control work and recommend areas for streamlining
• Participate in quality projects, as requested
• Bachelor’s degree preferred, preferably in a technical discipline; Minimum of Associates’ Degree
• 5+ yrs in a similar supervisory quality role
• Prior medical device experience
• Thorough knowledge of FDA Quality System requirements, ISO 13485
• ASQ Certification, or equivalent, is desirable
• Proven ability to supervise, direct, address performance issues, and develop a staff
• Excellent organizational, verbal, written communication and problem solving skills
• Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can do attitude, and motivated to succeed and grow
• Ability to multi-task with strong attention to detail
• Proficient in MS Office Suite, and of Statistical Process Control Practices
• Experience working in a start-up environment, helpful
• Self-driven and highly organized with the ability to work independently and cooperatively in a team setting

  • Principals only. Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers

post id: 6888377029


best of [?]