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Full-time
bachelor degree, professional certificate
Posted 10h ago
~40 hrs/week
Responsibilities
The Product Assurance Engineer will coordinate internal and supplier audits while managing quality metrics and CAPA processes to ensure product compliance. They will also lead process validation activities and support NPI projects through risk assessments and inspection protocol approvals.
Requirements
Candidates should hold a bachelor's degree or technical training with relevant experience in quality management systems like ISO9001 and ISO13485. Strong technical understanding, proficiency in quality methods, and the ability to work independently in a team-oriented environment are required.
Full 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.
Job Summary
This position is located in the Novanta Innovation Center Photonics in Wackersdorf and you will closely work together with the engineering teams in Wackersdorf and Bedford.
Continuous improvement of our products and processes from an R&D standpoint, as well as temporal and monetary optimization of our products in the different NPI phases and workflows applying internal and external audits
Primary Responsibilities
Organization and coordination of internal and supplier audits
Coordinate and support preparations for customer audits, certification audits and surveillance audits for Wackersdorf, including documentation review, audit planning and follow-up activities in cooperation with other Novanta locations.
Implementation of audits as well as definition of measures and follow-up of findings within the framework of CAPA's (corrective and preventive actions) for sustainable process optimization
Participation in NPI projects from a quality perspective (e.g. risk assessment, sample inspection, inspection and test requirements, assembly instructions, reliability tests, PFMEA, DFMEA etc.) & Evaluation and approval of FAI inspection protocols of new developed items
Conception and implementation of adapted Quality Management methods within task force teams to drive and improve the production and product development process
Steering of defective products (internal claims), analysis of error potentials and definition of targeted corrective measures, tw. within the framework of CAPA's
Supplier management in cooperation with purchasing dept. regarding current and new designed parts
Coordination of supplier RMAs and communication with the responsible external contact
Support the test equipment management with administration and update of the related tools (calibration/preventative maintenance process)
Program, maintain and run CMM inspection programs for dimensional verification of components and assemblies
Lead and manage the Wackersdorf product and part deviation permit program and engineering change activities, including coordination of the required review boards, meetings and cross-functional teams.
Lead IQ/OQ/PQ and process validation activities for new equipment, inspection methods, assembly processes, and production changes.
Own local quality readiness for production transfers and ramp-up, including validation support, inspection readiness, and release criteria for transferred products or processes.
Own Wackersdorf quality metrics and reporting, including but not limited to NCRs, internal defects, supplier quality, calibration compliance, audit findings, FPY, scrap/rework, and CAPA aging.
Investigate general assembly defects particularly in the early development stages, coordinate between production, engineering and quality
Required Experience, Education, Skills and Competencies
Studies (B.A., B.Eng.) or training as a technician (or comparable)
First experience in the relevant field of activity
Experience in management systems (ISO9001, ISO13485)
Experience of quality methods ( Pareto analysis, Ishikawa, cost-benefit, failure tree analysis, FMEA)
Technical understanding
Experience in the field of measurement technology desirable
Independent and careful work
Teamwork
Communicative nature
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.
Novanta is a leading global supplier of core technology solutions that give medical, life science, and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary expertise and competencies in precision medicine, precision manufacturing, robotics and automation, and advanced surgery with a proven ability to solve complex technical challenges. This enables Novanta to engineer proprietary technology solutions that deliver extreme precision and performance, tailored to our customers' demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation, the Novanta Growth System, and our customers’ success. Novanta’s common shares are quoted on Nasdaq under the ticker symbol “NOVT.”
Offices: 125 Middlesex Turnpike,, Bedford, Massachusetts 01730, US · 7279 William Barry Boulevard, North Syracuse, New York 13212, US · 100 Paramount Dr, Suite 101, Sarasota, Florida 34232, US · 4600 Campus Place, Mukilteo, Washington 98275, US · 3900 Atherton Rd, Rocklin, California 95765, US
Information TechnologyBusiness DevelopmentAdvanced MaterialsManufacturing
Novanta is a leading global supplier of core technology solutions that give medical, life science, and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary expertise and competencies in precision medicine, precision manufacturing, robotics and automation, and advanced surgery with a proven ability to solve complex technical challenges. This enables Novanta to engineer proprietary technology solutions that deliver extreme precision and performance, tailored to our customers' demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation, the Novanta Growth System, and our customers’ success. Novanta’s common shares are quoted on Nasdaq under the ticker symbol “NOVT.”
Offices: 125 Middlesex Turnpike,, Bedford, Massachusetts 01730, US · 7279 William Barry Boulevard, North Syracuse, New York 13212, US · 100 Paramount Dr, Suite 101, Sarasota, Florida 34232, US · 4600 Campus Place, Mukilteo, Washington 98275, US · 3900 Atherton Rd, Rocklin, California 95765, US
Information TechnologyBusiness DevelopmentAdvanced MaterialsManufacturing