Quality Assurance and Compliance Supervisor

2 weeks ago

Fort Myers Beach, Florida, United States Lenkbar LLC Full time

Position Overview:

The Quality Assurance and Compliance Supervisor at Lenkbar LLC plays a pivotal role in the implementation and upkeep of the Quality Management System (QMS). This position involves directing the QA team, collaborating closely with the Quality Control Supervisor, and maintaining a strong line of communication with the Global Regulatory Affairs/Quality Assurance Director to ensure adherence to FDA regulations and ISO 13485 standards. The supervisor will also contribute to ongoing improvement initiatives aimed at reducing defects and enhancing the effectiveness of the QMS.


Key Responsibilities:

  • Oversee quality management to ensure compliance with established standards and regulations.
  • Coordinate quality assurance activities by supervising personnel, managing production timelines, and optimizing workflow.
  • Collaborate with Operations management to proactively identify and mitigate potential quality issues.
  • Analyze job performance metrics and recommend actions for improvement.
  • Complete necessary administrative tasks, including report preparation and correspondence.
  • Work alongside Production and Materials Management to develop and oversee the QA/QC Department's production schedule.
  • Support the Quality Management System initiatives at Lenkbar LLC.
  • Partner with the Global Regulatory Affairs/Quality Assurance Director to enhance the QMS, develop quality policies, and drive continuous improvement.
  • Enhance relationships with customers and suppliers regarding quality standards and delivery timelines.
  • Research and evaluate new methods and technologies to improve inspection and testing processes.
  • Utilize critical thinking and coaching skills to implement effective quality principles for troubleshooting and root cause analysis.
  • Communicate updates and improvement strategies to all relevant departments and management.
  • Collaborate with the Director of QA and Regulatory Affairs on audits, non-conformance issues, and corrective actions.
  • Work with the General Manager to resolve customer-related issues, including product complaints and specifications.
  • Monitor vendor performance and establish criteria for vendor evaluation.
  • Lead internal and external quality audits to ensure compliance.
  • Plan and manage QA/QC staff duties and schedules.
  • Provide leadership and mentorship to all QA/QC personnel.
  • Assume full responsibility for hold-point releases in accordance with QMS protocols.
  • Identify and implement solutions to address inspection deficiencies.
  • Track defect trends and collaborate with responsible managers to develop improvement plans.
  • Perform additional duties as assigned.

Qualifications and Skills:

  • Minimum of 5 years of experience in Quality Assurance/Quality Control within the medical device manufacturing sector.
  • Strong critical thinking and coaching abilities, with experience in root cause analysis and corrective action implementation.
  • Proven leadership experience in managing quality teams.
  • Experience in machining environments is essential.
  • Familiarity with raw materials and production processes.
  • Comprehensive understanding of medical device regulations and quality concepts, including 21CFR FDA 820 and ISO 13485.
  • Ability to analyze complex problems and develop effective solutions.
  • Excellent communication skills across diverse teams and organizational levels.
  • Knowledge of Continuous Process Improvement methodologies, including Lean and Six Sigma.
  • Proficient in various software applications, including Microsoft Office.
  • Ability to work effectively under pressure and meet strict deadlines while maintaining professionalism.
Job Posted by ApplicantPro

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