DescriptionPosition Summary: 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.
Key Responsibilities:- 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 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.
Must Have:- Bachelor in STEM related field required. Advanced degree preferred.
- Minimum 7 years of experience in a regulated medical device environment, preferably as a Sr. or Principal Quality Engineer or Quality Manager, with supervisory and decision-making responsibilities.
- Quality and/or Regulatory certification(s) (ASQ, Lead Auditor, etc.).
- Knowledge and experience with external standards and regulations: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints.
- Experience with Class II and Class III medical device development and manufacturing.
- Demonstrable knowledge and experience with Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
- 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.
- Strong verbal and written communication skills. Ability to present complex information to internal and external contacts.
- Experience being a "Hands-on" self-starter with ability to work both independently and as part of a team.
- Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
- Experience in coaching and developing direct reports, utilizing performance management tools and disciplines, while increasing employee engagement and retention.
The pay range for this role is $140,000 - $165,000 a year. The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
