Sr. Quality Manager

Description

About us:

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 Sr. Quality Manager is primarily responsible for the Leadership and management of all site-level, Quality Engineering personnel and resources to ensure adherence and compliance to Cirtec Medical's Quality Management System and to support the organization's Manufacturing services. This position is designated as the site Management Representative.

• 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.
• 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 Quality Engineering support for internal and customer development programs and sustaining manufacturing process/continuous improvement efforts.
• 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.
• 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 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
• Planning (MRP) systems implementations, integrations, and improvements.
• Manage Quality Systems staff to provide Documentation Control and records retention functions,
• Incoming/Final Inspection, Complaint Analysis, Corrective Action System and Quality Control training to Customer Focused Business Units.
• Support and oversee the Nonconformance Materials Review Board process.
• Manage metrology and calibration activities.
• Primary lead for external regulatory, certification, and customer audits.

• Minimum Bachelor's degree in STEM/Engineering discipline
• Minimum 7-Years' experience leading quality in a manufacturing environment
• Quality and/or Regulatory certification(s) preferred (ASQ, RAPS, etc.).
• Knowledge and experience with external standards: ISO 9001, ISO 13485, FDA QMSR, EU MDR, pertaining to good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints.
• Experience in effectively managing audits by customers and regulatory agencies.
• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
• Experience with the preparation, review and catalogue of SOPs, Work Instructions, and other Quality Systems documents.
• Strong verbal and written communication skills. Ability to present complex data to internal and external contacts.
• Hands-on self-starter with…