Product Assurance Engineer

Novanta Inc.; Wackersdorf (VGem); Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Novanta Inc. in Germany seeks a Quality Assurance professional to drive internal and supplier audits, CAPA actions, and QMS improvements.

You will partner with engineering and production teams to ensure robust processes for product transfers and NPIs, with a focus on ISO9001/ISO13485 compliance and strong documentation practices. You will coordinate audit activities, support supplier quality, and implement risk-based methods across development and manufacturing.

Qualifikationen

• Bachelor's degree or technician training or equivalent
• Experience with quality management systems (ISO9001/ISO13485)
• Experience with quality methods (Pareto, Ishikawa, FMEA)
• Technical understanding for measurement technologies and processes
• Independent, careful, and team-oriented work
• Strong communication and documentation skills
• Experience in audits and CAPA processes is a plus

Aufgaben

• Organize and coordinate internal and supplier audits
• Support preparations for customer, certification, and surveillance audits with documentation review
• Implement corrective and preventive actions (CAPA) for process improvements
• Contribute to NPIs from a quality perspective (risk assessment, PFMEA, DFMEA)
• Lead quality readiness for production transfers and ramp-up
• Maintain quality metrics, NCRs, defects, and supplier quality reporting
• Coordinate with purchasing on supplier parts and RMAs

Kenntnisse

Quality management systems

Auditing

Documentation review

Independent work

Teamwork

Communication

Technical understanding

Ausbildung

Bachelor's degree or technician training

Tools

ISO9001

ISO13485

Jobbeschreibung

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 [phone] if you need a disability accommodation for any part of the employment process.