Job description
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. Primary Responsibilities Lead and coordinate quality and validation activities related to production transfers and manufacturing changes.
Create, review, approve validation documentation including plan / protocols, reports, process control plan and associated controlled documentation. Participate in process, equipment and manufacturing validations and ensure compliance with applicable quality and regulatory requirements. To ensure that validation activities are appropriately planned, executed, and documented to maintain compliance of manufacturing processes, equipment, and associated documentation within controlled manufacturing and cleanroom environments.
Participate in transfers of products and manufacturing processes between Novanta sites from a quality and validation perspective. Collaborate closely with Project Management, Regulatory Affairs, Operations and Quality teams to ensure successful implementation of changes. Create, review, approve risk management documentation (PFMEA).
Evaluate impact of manufacturing changes to validation status and support implementation activities. Support internal, customer and certification audits. Support root cause investigations and continuous improvement activities using appropriate quality tools Required Experience, Education, Skills, Training and Competencies Experience working in a regulated manufacturing environment such as medical devices, pharmaceuticals, biotechnology, food supplements or similar industries Hands-on experience with validation activities and controlled documentation Knowledge of quality standards and regulations (ISO 13485, ISO 9001, GMP or similar) Experience working in cleanroom or controlled manufacturing environments is highly desirable Ability to work independently while collaborating effectively within cross-functional teams Strong documentation and communication skills Fluent Czech and English What we offer The opportunity to work for a stable international company developing and manufacturing medical devices The chance to contribute to international projects and collaborate with colleagues across global sites Flexible working hours Hybrid working model with up to 2 days of home office per week 25 days of annual leave Free lunches Company contribution to pension savings Edenred benefits card Transportation allowance Employee referral bonus Annual salary review based on performance 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.