Quality Director

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.

The Site Quality Leader (Director) is responsible for driving continuous quality improvements and presenting internal and external customer-oriented needs to site leaders and business unit partners. This includes taking a leadership role in implementing critical quality control initiatives in the manufacturing, receiving, and product release for medical devices. Additionally, the Site Quality Lead at the Prelouc site will identify and facilitate key competencies at the site that give the quality organization a competitive advantage. In this role, they coordinate regional efforts regarding compliance, technology investments, regulations, and resource management/optimization.

Responsibilities include collaborating on programs that can impact site operations from a regulatory, compliance, or optimization perspective. Additionally, this role will work closely with the new product introduction teams to ensure standard practices for product launch stabilization (compliance and efficiency) are in place.

Main responsibilities: 

• Ensuring the implementation of the quality management system at the site and applying tools and methods for process excellence for continuous improvement and predictability.
• Maintains a deep understanding of the regulations and standards for quality systems related to the medical devices manufactured at the site, including but not limited to US FDA 21 CFR parts 820, ISO13485, Canadian Medical Device Regulations, European Medical Device Regulations, ANVISA, TGA, Japan MHLW, and China GMP.
• Reports to top management key performance indicators on the performance of the quality management system and any required improvements.
• Describes important tasks or duties not mentioned above that are rarely performed and are not critical to fulfilling the essential functions of the job.
• Develops a world-class quality organization through talent acquisition and internal movements to support our projected growth.
• Ensures that awareness of regulatory and customer requirements is promoted throughout the production facility.
• Ensures that the quality system is regularly audited/reviewed and that necessary changes are implemented as needed.
•  Acts as a pioneer by recommending appropriate compliance efforts and proposing quality system improvements.
• Ensures that all employees are trained and educated in legal requirements.
• Ensures that the site has the appropriate resources with the right competencies to implement the quality system.
• Maintains systems that ensure only acceptable raw materials are used in processes and only acceptable materials are shipped.
• Has the authority to stop production/shipment when quality requirements are not met.
• Reviews and acts as the approving authority or delegated authority, retaining responsibility for all specifications, protocols, validations, and non-conformities.
• Leads, promotes, and adheres to all safety and occupational hygiene rules and regulations established by the company.

Qualifications:

·                Bachelor degree or similar in quality / regulatory, business, engineering or science with a minimum of 10 years’ experience

Required knowledge, skills, abilities:

·                 Functional knowledge/experience in Quality & Compliance. 

·                Proficiency in both spoken and written English  is required. Preferable German language skills

·                In-depth knowledge of the regulated medical device industry and strong business acumen

·                preferable knowledge in sterile medical devices.

• A transformative, strategic problem solver with superior ability to bring clarity to complex concepts and mobilize and align the organization to implement strategy and translate strategy into financial forecasts and business plans.
•  Experience in developing and implementing long-term financial plans and annual business plans for departments.
•  Experience in leading organizations through cost optimization activities and advising on opportunities.
• Ability to analyze and translate financial data to provide effective trade-off recommendations in the Q&C portfolio of strategic investments to balance risks while leading through changes.
• Experience in setting up and managing program portfolios and reporting progress against investments and savings.
• Experience in creating business cases and capital allocation requests.
• Build interdependent partnerships and both internal and external relationships.
• Superior team-building and inclusion-promoting skills.
• Strong mix of tactical and strategic management skills with the ability to influence partners while managing competing internal stakeholder priorities.
• Excellent interpersonal skills and the ability to interact effectively with all levels of the organization.
• Proven ability to build and maintain effective working relationships with diverse groups of people in a global and matrixed organization.
• Positive relationship development, conflict resolution, and team-building instinct with the ability to build partnerships both internally and externally.

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.