Manager, Global Quality Management Systems

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications-from minimally invasive surgery to robotics to 3D metal printing.

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

Summary

The Global Quality Management Systems Manager will implement and drive maintenance of quality system requirements, including document management, audits, CAPA, quality metrics reporting, management review, and training.

Global Activities:

• Developing and maintaining relationships with external stakeholders, including regulatory bodies and customers.
• Key owner and facilitator for Regulatory and Notified Body Audits, including ownership of corrective actions for any nonconformities identified.
• Key owner and facilitator of the Internal Auditing Program, including ownership of corrective actions for any nonconformities identified.
• Key owner and facilitator of all Bedford Customer Audits, including ownership of corrective actions for any nonconformities identified. Dependent on the opportunity, this individual may need to support customer audits of international sites.
• Corrective and Preventative Action Management, ensuring all CAPAs are addressed within corporate targets.
• Key owner, presenter, and facilitator of Annual Management Review and Monthly Quality Operational Reviews.
• Key owner of the Global Training Program.
• Owner of the transition of the Global Quality Management System into an Integrated Management System for more comprehensive and complete business processes.

Bedford Site-Level Activities:

• Responsible for all Bedford auditing activities to maintain compliance with various ISO standards.
• Reporting on site-level Quality Objectives and KPIs during Monthly Operations Review.
• Corrective and Preventative Action Management, ensuring all Bedford CAPAs are addressed within corporate targets.

Required Experience, Education, Skills, Training and Competencies

• Bachelor's degree in engineering or related field.
• 8+ years of related quality experience encompassing QA systems management, Supplier quality and/or mfg. quality.
• Three (3) years in supervisory or leadership roles.
• Robust working knowledge of software solutions for QMS.
• Demonstrated ability to coordinate process improvement initiatives and quality system related projects.
• Possess excellent analytical skills and a keen eye for detail.
• Have excellent communication and interpersonal skills.
• Technical Knowledge: Understanding engineering principles, manufacturing processes, and quality assurance techniques. Familiarity with med tech, life sciences, and advanced industrial markets is crucial.
• Quality Assurance: Knowledge of quality systems and standards in the med tech and life sciences industries. Ability to conduct quality system assessments and implement quality control measures. Including knowledge and experience with ISO9001, 13485, 14001, 45001, 27001 & 22301.
• Regulatory Compliance: Understanding of regulatory standards and requirements in the advanced industrial, med tech and life sciences industries.

Travel Requirements

• Up to 10% domestic and international travel to customer, supplier and/or Novanta locations.
  

Physical Requirements

• Must be able to lift 25 lbs.
• Job is performed while sitting or standing.

Novanta is proud to be an equal employment opportunity and affirmative action workplace. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.

Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.