Director of Quality Systems — Medical

Our client is seeking a Director of Quality Systems northwest of Boston, MA who is an experienced expert in operating ISO certified facilities. The Director of Quality Systems will lead the quality team in developing and executing Quality operations in-line with our client’s mission and vision. The Director of Quality Systems will implement and monitor all company quality systems to demonstrate compliance with all regulatory requirements, including ISO 13485. This position is responsible for providing quality guidance for design, development, and manufacturing strategies related to the production of parts for multiple industries, including medical.

The Director of Quality Systems must have knowledge of quality systems and compliance to support systems, software, and service. This position is accountable for ensuring the Quality Management System (QMS) is defined and executed to meet all supplier management, manufacturing, new product development, quality control testing, and shipping activities. QMS compliance will be met by ensuring that activities previously noted are conducted according to prescribed procedures, policies, and regulations. The role will also be responsible to lead, manage, and coach the Quality team.

Director of Quality Systems – Medical, specific responsibilities include:

• Evaluate production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements. Develop, implement and maintain quality management systems, policies, procedures and standards in compliance with regulatory requirements such as ISO 13485 and FDA regulations for medical devices.
• Lead the development and implementation of quality control processes and procedures.
• Develop and implement a comprehensive audit program to assess compliance with quality systems regulations and standards.
• Collaborate with cross-functional teams to ensure product quality, regulatory compliance and timely resolution of quality issues.
• Develop and implement training programs to ensure that employees understand quality requirements and procedures.
• Identify opportunities for continuous improvement in quality systems and processes.
• Manage and mentor the quality team to ensure their continued growth and development.
• Develop an internal audit program that meets applicable sections of ISO and FDA regulations in all facilities.
• Manage the specifications and forms on the company intranet site.
• Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance.
• Conduct random inspections and quality control checks.
• Assure that KPIs are in place, measured, and successful.
• Update and create additional reports and post the results in both facilities.

Director of Quality Systems – Medical, Background profile:

• Bachelor’s degree in a relevant field such as engineering, science or quality management.
• At least 10 years of experience in quality management, preferably in a medical device or regulated industry.
• Strong knowledge of quality management systems, regulations and standards, including ISO 13485 and FDA regulations.
• Experience leading cross-functional teams to achieve quality goals.
• Excellent communication, interpersonal and leadership skills.

Director of Quality Systems – Medical, Preferred background:

• Master’s degree in a relevant field.
• Experience with risk management and validation processes for medical devices.
• Experience working with regulatory bodies such as the FDA, notified bodies and health authorities.
• Six Sigma or Lean Manufacturing certification.

Tagged as: compliance, FDA, ISO 13485, manufacturing, medical device, QMS, regulatory, supplier