Quality Manager

Pay: $57-$67/hr

Essential Duties and Responsibilities:

• Manage and oversee the implementation and maintenance of the quality management system, ensuring compliance with ISO 9001, ISO 13485, and CFR 820

• Lead Management Review meetings, reporting quality data results and providing insights to senior management to drive strategic decision-making

• Host external audits, including customer audits and regulatory inspections, and ensure timely resolution of any findings or non-conformities

• Provide leadership and direction to the Quality Engineering, Incoming Inspection, and Quality Control teams, ensuring effective management of resources and adherence to quality standards

• Serve as the lead auditor for ISO 9001 and ISO 13485 certifications, conducting internal audits and leading audit teams to assess compliance and drive improvement

• Liaise with customers to address quality-related inquiries, concerns, and requirements, ensuring a high level of customer satisfaction

• Collaborate with cross-functional teams to identify and mitigate organizational risks related to manufacturing processes and product quality

• Provide training and guidance to employees on quality management principles, regulatory requirements, and best practices

• Stay informed about changes in regulatory requirements and industry standards, and proactively implement necessary changes to maintain compliance

• Drive a culture of quality excellence and continuous improvement throughout the organization, leading by example and fostering a collaborative and supportive work environment

Minimum Qualifications and Experience:

• Manage and oversee the implementation and maintenance of the quality management system, ensuring compliance with ISO 9001, ISO 13485, and CFR 820

• Lead Management Review meetings, reporting quality data results and providing insights to senior management to drive strategic decision-making

• Host external audits, including customer audits and regulatory inspections, and ensure timely resolution of any findings or non-conformities

• Provide leadership and direction to the Quality Engineering, Incoming Inspection, and Quality Control teams, ensuring effective management of resources and adherence to quality standards

• Serve as the lead auditor for ISO 9001 and ISO 13485 certifications, conducting internal audits and leading audit teams to assess compliance and drive improvement

• Liaise with customers to address quality-related inquiries, concerns, and requirements, ensuring a high level of customer satisfaction

• Collaborate with cross-functional teams to identify and mitigate organizational risks related to manufacturing processes and product quality

• Provide training and guidance to employees on quality management principles, regulatory requirements, and best practices

• Stay informed about changes in regulatory requirements and industry standards, and proactively implement necessary changes to maintain compliance

• Drive a culture of quality excellence and continuous improvement throughout the organization, leading by example and fostering a collaborative and supportive work environment