Quality Manager Jobs

The Quality Manager will be responsible for the leadership and management of Quality personnel and resources to ensure compliance to the Quality Management System. This 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.

ESSENTIAL RESPONSIBILITIES

• Complies with company, safety and quality standards, policies, and procedures.
• Responsible for ensuring the promotion and awareness of applicable regulatory requirements and Quality Management System requirements throughout the site’s organization.
• Responsible for ensuring that the processes needed for the Quality System requirements are established and maintained in accordance with applicable regulations and standards.
• 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.
• 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.
• Manage metrology and calibration activities.
• 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.
• Responsible for leading Management Review meetings and reporting the performance and effectiveness of the Quality System, as well as any improvements needed, for periodic review and analysis.
• Manage Quality Control staff to provide incoming (receiving & inspection), in-process inspection, final inspection, and product release activities for all manufacturing programs.
• 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.
• 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.
• Responsible for oversight and compliance of the Quality Management System.
• Responsible for overseeing or delegating the creation of QMS related Quality Plans that are site-specific.
• Manage support for local and corporate Documental Control (PLM) and Material Resource Planning (MRP) systems implementations, integrations, and improvements.
• Act as site champion for Quality Best Practices and cGMP
• Drive and support corporate Quality Management System initiatives.
• Ensure accountability for Design Controls and DHF management of internal and customer development programs and design transfers.
• Develop and perform qualifications and validations for manufacturing processes in collaboration with cross-functional engineering teams per project requirements.
• Oversee Complaint Analysis and Corrective and Preventive Action Systems, and the tracking / reporting of metrics.
• Primary lead for external regulatory, certification, and customer audits.

QUALIFICATIONS

• 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.
• Bachelor of Science or equivalent experience, preferably in an engineering discipline.
• 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.
• Experience in effectively managing audits by customers and regulatory agencies.
• 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.
• Quality and/or Regulatory certification(s) preferred (ASQ, Lead Auditor, etc.).
• Experience with Class II and Class III medical device development and manufacturing.
• 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.