Quality Engineer

Posted 3 Days Ago
Be an Early Applicant
Bedford, MA
In-Office
69K-100K Annually
Senior level
Appliances • Industrial • Manufacturing
The Role
Support and improve QMS to ISO 13485/9001, manage supplier qualification and audits, oversee FAI/MRB/SCAR/CAPA, develop test/inspection methods, drive process improvements, and implement computer-based quality processes and training.
Summary Generated by Built In

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.

In this exciting and challenging role you will work for Cambridge Technology, Inc. Cambridge Technology (CTI) is a global leader in galvanometer-based scanning technology and associated mirrors. These products are used in various laser-based applications including medical devices, rapid prototyping, converting, marking, and coding and many more. Cambridge Technology’s products deliver up to 1 micron accuracy and marking speeds of over 1,000 characters per second. 

 

Essential Functions: 

  • Support, maintain, and improve QMS to ISO 13485 and 9001 standards 

  • Conduct supplier QMS audits and support internal and external QMS audits 

  • Develop and manage supplier qualification and management program 

  • Manage FAI process 

  • Develop and manage MRB, SCAR, CAPA processes  

  • Generate, review, and approve Engineering Change Orders 

  • Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products 

  • Use data to drive process improvements  

  • Design and implement computer-based quality system processes, including development of training 

 

Job Qualifications: 

  • Comprehensive root-cause investigation experience and solid understanding of corrective and preventive action processes including the applicable tools and techniques. 

  • Must be detail-oriented, be able to accurately prepare statistical reports and technical documents in support of company objectives. 

  • Must have proven leadership experience coordinating company cross-functional team members and external supplier representatives. 

  • Excellent critical thinking and problem-solving skills 

  • Detail-oriented problem solver who is schedule-orientated  

  • Ability to work independently, as part of a larger cross-functional team and/or lead cross-functional teams comprised of Cambridge Technology colleagues and supplier representatives 

 

Required Education: 

  • Bachelor’s Degree in Engineering or related discipline 

 

Required Experience: 

  • 5+ years of related experience in Quality or related field 

  • Working knowledge of ISO 13485 

  • Working knowledge of risk management processes 

  • Strong leadership and communication skills 

The salary for this role will range from $69,075 to $100,000 annually based on full-time employment. Salary offers are based on a wide range of factors including but not limited to location, relevant skills, training, experience, education, etc. Certain roles may be eligible for performance-based incentive compensation and/or long-term incentives. Incentives could be discretionary or non-discretionary depending on the plan. Novanta supports all aspects of your life's needs. This position provides a full range of medical, financial, and other aspects to make your quality of life better.

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.

Top Skills

Iso 13485,Iso 9001,Qms,Fai,Mrb,Scar,Capa,Engineering Change Orders,Process Control Systems,Risk Management
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The Company
Manchester
2,075 Employees

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)

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