Complaint Specialist (m/w/d)

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Complaint Specialist (m/w/d)

Apply locations Ludwigsstadt, Germany time type Full time posted on Posted Today job requisition id R008043

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.

This position is part of Novanta’s Advanced Surgery business unit group. Novanta offers highly reliable, precise and safe solutions that enhance system performance and improve patient outcomes.

Summary

In compliance with European MDD/MDR, FDA & other International Regulations, the Complaints Specialist will perform work under general management supervision. General scope of this position is to ensure compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting, complaint follow-up, coordination of complaint device returns, and collaboration with the cross-functional engineers and technicians for timely completion of the complaint investigation. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Primary Responsibilities

• Processing of customer feedback (“complaints”), taking into account the requirements of ISO 13485 and all relevant medical device regulations.
• Central recording of information by customers and sales/marketing Novanta about malfunctions and application problems.
• Analysis of defective products (internal and customer, supplier complaints) using quality tools (8D report, 5WHY and others).
• Evaluation of the analysis results to develop and initiate corrective and preventive measures.
• Evaluation of the analysis results with regard to complaint category (A, B, C or D), information to RA and QMB/safety commissioned for categories C and D.
• Reporting to the customer (and the relevant internal areas).
• Documentation of processes in accordance with regulatory requirements.
• Regular evaluation of processes (monthly and annually).
• Processing customer feedback on non-medical devices (taking into account the requirements from ISO 9001).
• Recording, analyzing, evaluating and documenting customer feedback on non-medical products.
• Close cooperation with Quality Operations Supervisor and quality engineer Supervisor.
• Working with SAP – different operations (e.g. complaints, material, etc.).
• Participates in meetings for the launch of new projects.
• Cooperation on customer, internal quality audits.
• Different types of analysis (scrap, error rate).

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 and participation in the innovation process.
• Strict compliance with quality, safety and environmental regulations and implementation of the instructions of quality.
• German and English language very good (used daily).

Travel Requirements

• The willingness to travel to all Novanta locations and business contacts of Novanta (less than 20% 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.