Quality Manager

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$97,900.00/yr - $/yr

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at  and

QTS is currently seeking an experienced, energetic, responsive, and well-organized full time Quality Manager. This position will be responsible for building, managing, and leading the quality department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality products to the QTS Quality Management System. This role will support our customer facing function to ensure customer requirements are met, drive quality customer communications, and support the quality and delivery of the products.

This position will ensure the products and processes meet the quality management system requirements and methods in alignment with the FDA QSR and ISO requirements and utilize metrics to continually improve quality processes and efficiency.
This would be an on-site position.

• Establish and lead a high-performing team of Quality Engineers, Quality Technicians, and Customer Facing Quality, providing mentorship and coaching to staff as needed.
• Manage customer quality communication and relationships. Assist in the resolution, documentation, customer responses for complaints.
• Execute quality policies, quality objectives, and quality plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements.
• Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines.
• Professional and timely cross functional communication with other departments and customers.
• Monitor and assess the QMS processes for compliance, effectiveness, and opportunities for improvement, ensuring product meets requirements and continued certification to applicable standards.
• Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality of products. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate.
• Assures in process inspection, batch record review, sterile and product release complies with the quality system.
• Support the Management Review process. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause - corrective action.
• Support a culture of Operational Excellence, inclusive of lean and six sigma principles.
• Act as the Deputy Management Representative should need arise.
• Act as a representative for customer audits, and support external audits by regulatory authorities and registration agencies.

• Bachelor's degree in Engineering, Sciences, Quality, or relevant experience.
• 8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field.
• 3 years of leadership experience.
• Clear and effective verbal and written communication skills.
• Strong attention to detail and organizational skills.
• In depth knowledge of 13485, 14971, FDA Quality System Regulation, 21
  
  CFR Part 820, Good Manufacturing Practices, or other relevant regulated requirements.
• Experience with Corrective and Preventative Actions, including the ability to lead cross functional teams to solve problems and complete root cause analysis.
• Working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma - an asset.
• Demonstrated leadership skills with the ability to build, mentor and maintain an efficient, effective organization with a team focused on continual improvement and holds team members accountable.
• Experience with…