Quality Manager

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

The Quality Manager will be responsible for the leadership and management of Quality personnel and resources to ensure compliance to Cirtec Medical’s Quality Management System. The Quality Manager may be the designated Management Representative for the Quality Management System. The Quality Manager will also be responsible for overseeing Quality engineering activities to support sustaining manufacturing operations, and product development programs.

• Responsible for oversight and compliance of the Quality Management System.
• Responsible for ensuring that the processes needed for the Quality System requirements are established and maintained in accordance with applicable regulations and standards.
• Responsible for ensuring the promotion and awareness of applicable regulatory requirements and Quality Management System requirements throughout the site’s organization.
• Responsible for leading Management Review meetings and reporting on the performance and effectiveness of the Quality System, as well as any improvements needed, for periodic review and analysis.
• Oversee Complaint Analysis and Corrective and Preventive Action Systems, and the tracking / reporting of metrics.
• Lead and manage the Quality Engineering staff responsible for Design & Development as well as Sustaining Manufacturing activities.
• Manage Quality Control staff to provide incoming (receiving & inspection), in-process inspection, final inspection, and product release activities for all manufacturing programs.
• Responsible for overseeing or delegating the creation of QMS related Quality Plans that are site-specific.
• Provide organizational leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
• Drive and support corporate Quality Management System initiatives.
• In partnership with other Cirtec Medical Quality Leaders, ensure establishment and maintenance of site registrations (e.g., ISO 13485 and FDA).
• Act as site champion for Quality Best Practices and cGMP within Cirtec Medical.
• Ensure accountability for Design and Development management of internal and customer development programs and design transfers.
• Provide Quality Engineering support for internal and customer development programs and sustaining manufacturing process/continuous improvement efforts.
• Initiate and/or collaborate in the generation/update of process / product Risk Management documentation, e.g., FMEAs and Hazard Analysis, in collaboration with cross-functional engineering teams.
• Develop and perform qualifications and validations for manufacturing processes in collaboration with cross-functional engineering teams per project requirements.
• May author, review and/or approve documentation for process and design change activities as well as validation / verification oversight and/or test method execution in cooperation with cross-functional engineering teams per project requirements.
• Represent Quality Engineering in program / project phase reviews throughout the product development and transfer to manufacturing phases and process improvement initiatives.
• Support and oversee the Nonconformance Materials Review Board process.
• Manage metrology and calibration activities.
• Primary lead for external regulatory, certification, and customer audits.
• Manage support for local and corporate Documental Control (PLM) and Material Resource Planning (MRP) systems implementations, integrations, and improvements.
• Manage Quality Systems…