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Quality Assurance/Quality Control Manager

3 months ago

Naples, United States Lenkbar LLC Full time
Job DescriptionJob Description

Position Summary:

The QA/QC manager is responsible for ensuring that the Quality Management System (QMS) is fully implemented and maintained in an organized and efficient manner; is responsible for delegating and assigning tasks to QA team and working closely with QC Supervisor; will report and work closely with Global RA/OA Director to ensure that FDA regulatory and ISO 13485 requirements are met, product quality is in conformance with the regulations, and that the customer's requirements are met; will assist and support in continuous improvement efforts and defect reduction initiatives to establish an effective QMS.


Essential Duties and Responsibilities:

  • Manage and oversee project quality to ensure compliance to standards, regulations and QMS requirements.
  • Coordinate quality activities by supervising staff; organizing and managing production schedules, monitoring work flow and expediting work as necessary.
  • Works closely with the Operations management to identify potential quality issues before they arise and take preventative actions to prevent problem occurrence.
  • Monitors and analyzes job results and recommends actions as necessary to improve performance.
  • Performs required administrative tasks including preparation of required reports and correspondence.
  • Works closely with Production Management and Materials Management to develop, communicate and supervise the QA/QC Department production schedule.
  • Provide support as Quality Management System to Bradshaw Medical.
  • Work with Global RA/QA Director to sustain and lead improvement to the Quality Management System, develop and implement Quality policy, plans and procedures, and drive continuous improvement and provide leadership and project management.
  • Work with the Global RA/QA Director to improve the customers and supplier's relationship regarding standards for precision, capability, quality and on-time delivery.
  • Researches, investigates, and tests new methods, technologies, equipment, and systems in the fields of quality, inspection, and manufacturing that will improve the overall levels of performance in manufacturing inspection and testing.
  • Critical thinking skills a must and capable of coaching, developing, and using key quality principles for trouble shooting and root cause analysis such as 5-whys, cause and effect, Pareto analysis and validated root cause to identify effective corrective actions and process improvements.
  • Communicates status updates and improvement plans to all departments and management teams.
  • Works cohesively with the Director of QA and Regulatory department regarding audits, non-conforming product, CAPA's, SCAR's, Complaints, etc.
  • Partner with General Manager to drive the resolution of customer driven issues including product complaints, rework, specifications, and processes impacting lead time.
  • Monitors vendor performance and the establishment of criteria and rating system for critical vendors.
  • Active lead in internal and external quality audits to ensure compliance and successful results.
  • Planning duties within the QA/QC staff and related work schedules.
  • Providing leadership, mentorship, and direction of all QA/QC personnel
  • Taking full responsibility for hold-point releases once all QMS functions.
  • Identify and develop solutions to correct inspection function deficiencies.
  • Follow up on defect trends - meet with responsible managers, develops improvement plans, provides historical data, etc. Documents non-conformances and facilitates a timely disposition.
  • All other duties as assigned.

Knowledge, Skills & Competencies:

  • 5 + years' working experience and knowledge in Quality Assurance/Quality Control and/or Regulatory in a manufacturing environment within the medical device industry, quality control, and risk management, supplier audits, CAPA and complaint handling.
  • Critical thinking skills and experience coaching, developing, and using key quality principles for trouble shooting and root cause analysis such as 5-whys, cause and effect, Pareto analysis and validated root cause to identify effective corrective actions and process improvements.
  • Prior experience leading a quality team.
  • Previous experience in a machining environment required.
  • Knowledge of raw materials and production processes.
  • Sound understanding of the principles of the various products.
  • High energy and results-oriented individual who is successful in a business environment and is skilled in motivating and inspiring people.
  • Mid-size company "hands on experience"
  • Knowledge and understanding of medical device regulations and quality concepts (21CFR FDA 820) and ISO 13485.
  • Ability to identify complex problems and review related information to develop and evaluate options and implement solutions.
  • Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization.
  • Knowledge and experience in the implementation of Continuous Process Improvement, Lean and Six Sigma.
  • Capable of handling stressful situations and manage conflict.
  • Computer literate in various software applications (i.e. Microsoft Office).
  • Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor.


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