Supervisor Design Assurance (m/f/d)

Novanta Inc.; Berlin; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Novanta Inc. seeks an experienced leader to head the Design Assurance team in Berlin, driving quality plans, V&V strategies, and regulatory compliance for medical device projects.

You will review design Controls, manage risk per ISO 14971, and support product development with NC/CAPA activities, while fostering a high-performing, compliant team in a regulated environment.

Qualifikationen

• Degree in engineering, physics, or a related technical field.
• Minimum 5 years in a regulated industry.
• Prior team leadership experience is advantageous.

Aufgaben

• Provide first-level leadership to the local Design Assurance team in Berlin.
• Create quality plans and V&V strategies for medical devices.
• Review design control documentation to ensure GLP, GDP, and FDA 21 CFR 820 compliance.
• Participate in risk management (ISO 14971) and ensure evidence of effectiveness.
• Contribute to Product / Design FMEA and calibration of measuring equipment.
• Support NC/CAPA activities per ISO 13485 and drive process improvements.
• Ensure adherence to quality, safety, and environmental regulations.

Kenntnisse

Leadership

Quality management

Risk management

ISO 13485

Regulatory compliance

GLP/GDP knowledge

Communication

Quality analytics

Team development

Ausbildung

Degree in Engineering, Physics, or related technical field

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.

Your Responsibilities

Team Leadership

• Provide first-level leadership to the local Design Assurance team in Berlin
• Coordinate and supervise daily activities and priorities
• Ensure tasks are completed efficiently and in line with defined processes
• Support, motivate, and develop team members to build and maintain an engaged and high-performing team

Design Assurance & Development Support

• Create overall quality plans, including document plans and V&V strategies
• Create and review design verification and validation plans for medical devices
• Review Design Control documentation in compliance with GLP, GDP, and FDA 21 CFR 820
• Risk Management (ISO 14971)
• Act as a member of the risk management team
• Ensure: Completeness and consistency of risk analyses
• Evaluation of risk control measures, including impact on severity and probability
• Availability of evidence for implementation and effectiveness of measures

Product Development & Quality Activities

• Contribute to Product / Design FMEA activities
• Support the creation of test specifications for series testing in cooperation with Quality Assurance
• Manage, maintain, and adjust calibration of measuring equipment
• Perform failure analysis of non-conforming units
• Initiate and actively support process improvements and harmonization activities
• Support and perform NC/CAPA activities in accordance with ISO 13485

Compliance & Standards

• Ensure strict adherence to: Quality requirements
• Occupational safety regulations
• Environmental regulations
• Follow and implement instructions from Quality and Environmental Management and Occupational Safety functions

Your Profile

Education & Experience

• Degree in Engineering, Physics, or a related technical field
• 5 years of professional experience in a regulated industry
• Prior team leadership experience is an advantage

Professional Skills

• Experience in product quality within highly regulated industries (medical devices preferred; automotive or aviation accepted)
• Knowledge of ISO 13485 and quality management systems
• Experience with quality and statistical methods
• Experience in system, reliability, software, or hardware testing

Personal Competencies

• Strong ability to lead, motivate, and develop teams
• Ability to coordinate tasks and assess team capabilities effectively
• Clear and professional communication across all organizational levels
• Structured, systematic, and quality-focused working style
• High level of reliability and integrity

Additional Requirements

• Fluent in English (minimum B2 level)
• Willingness to travel (approx. 10%)

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.

Solving complex challenges, delivering innovations that matter! 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".