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
· Manages and ensures production transfers and their readiness according to overall time-lines of transfer programs – from a quality point of view
· Ensures alignments with Project Manager and other involved internal departments (Regulatory, Quality, Operations, Finance and Controlling)
· Close cooperation with Quality Operations Supervisor and Quality Engineer Supervisor NMC
· Close cooperation with Quality Ludwigstadt and Quality Berlin
· Responsibility for documentation connected with transfers e.g. part history.
· In collaboration with other departments to review and update of process FMEAs for preventive failure avoidance.
· Update of control plans in relation to transfers (launch and serial production)
· Participates in meetings for the launch of new projects
· Cooperation on customer, internal quality audits
· Plan and perform quality activities for changes in production, e.g. Control Plan, PPAP, support P FMEA
· Define release criteria for production related changes
Required Experience, Education, Skills, Training and Competencies
· Knowledge of EN ISO 13485 and EN ISO 9001 standards
· Knowledge of quality tools (5Why, Ishikawa, 8D report)
· Orientation in technical documentation
· Knowledge and active uses of the MS office package
· Focused, reliable and independent working style
· Active approach to the validation process
· Excellent knowledge of English language (used daily)
· Knowledge of German is an advantage
Travel Requirements/ Požadavky na cestování
· The willingness to travel to all Novanta locations and business contacts of Novanta (less than 30% of working time)
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.
Skills Required
- Knowledge of EN ISO 13485 and EN ISO 9001 standards
- Knowledge of quality tools (5Why, Ishikawa, 8D report)
- Excellent knowledge of English language
- Knowledge of German is an advantage
- Orientation in technical documentation
- Active approach to the validation process
- Focused, reliable and independent working style
What We Do
Novanta delivers innovations that matter for its medical and advanced industrial OEM customers. If you have a passion for solving complex technical problems that lead to breakthrough performance and that enhance people's lives, come join our growing team. Here is a sample of the many exciting applications we serve: • Innovations that ensure the safety of patients and efficient workflows in hospitals using our novel RFID technology • Innovations in additive manufacturing, also known as 3-D metal printing, using our lightning fast lasers and laser beam steering sub-systems • Innovations in minimally invasive surgery using our highly reliable insufflators, pumps and visualization systems • Innovations in robotics and automation using our precision motors, encoders and drives for superior accuracy • Innovations in smartphone production using our fast, accurate lasers and laser beam steering equipment along with our precision motion systems The driving force behind our growth is the team of talented professionals who share our commitment to our values, and our passion for innovation and for our customers’ success. Novanta has deep expertise in precision medicine and manufacturing, medical solutions, and robotics and automation: Precision Medicine and Manufacturing: • Continuous wave, ultrafast and CO2 lasers, along with laser beam steering components and sub-systems Brands: ARGES, Cambridge Technology, Laser Quantum, Synrad Medical Solutions: Minimally Invasive Surgery: • Insufflators, pumps and disposable tube sets; medical visualization systems, video processing and wireless imaging Brands: NDS, Med X Change, Reach Technology, WOM Detection & Analysis: • RFID readers, machine vision solutions, barcode scanning, light and color measurement Brands: JADAK Robotics and Automation: • Motors, encoders, servo drives, air bearing systems and integrated mechatronic solutions Brands: ATI, Celera Motion (inc. Applimotion, Ingenia, MicroE, Zettlex, Westwind)
