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Sr. Director Global Design Quality

Company: Waters Corporation
Location: Milford
Posted on: September 12, 2020

Job Description:

This role will lead and manage the overall Global Design Quality function, supporting Software, Instrument, Chemistry and Clinical (IVD) product development. This role will be key in building and strengthening partnerships across each of these business areas by providing quality support and solution based decision making to enable delivery of the product roadmap and drive continuous improvement. This is a key leadership position supporting and driving growth through innovation within Waters, while generating a strong Quality culture and customer first mindset.

Key partnering organizations include, Global Products, Operations (e.g. manufacturing, supply chain), Global Service Support, Chemistry and Clinical functions.

This role reports to the VP Global Quality & Regulatory and leads the following teams/sites:

- Milford, MA – Instrument (LC) and Chemistry Design

- Wilmslow, UK – Instrument (MS) Design

- Wexford IE – Clinical Business Design

- Wilmslow, UK & Brasov, RO – Software Design

Responsibilities Strategic Activities: 15%

Lead the Global Design Quality function for Waters Corporation, with emphasis on global strategy for in-vitro diagnostic clinical business activities as well as ISO 9001 products.

Provide leadership and direction on all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance and product performance.

Participate in the development and implementation of Global Quality strategy and accomplish the key performance objectives as applicable to the Global Design Quality function.

Build strong working relationships with all internal partnering functions, industry experts, regulatory agencies and customers.

Supports and enables on-time delivery of the new product roadmap for Waters

Core Activities: 50%

Ensure highest product quality and systems are implemented and executed by providing interpretation and guidance on quality standards, regulations and directives including industry and best practices

Drive the harmonization and rationalization of product development related processes to achieve maximum efficiency and a firm foundation of regulatory compliance

Provide coaching, training, mentoring, solution based guidance, and act as a functional expert by providing appropriate guidance to the business

Participate and provide input on Project Review Boards (PRB’s), reporting on process, design quality and customer satisfaction performance.

Monitor and report the effectiveness and efficiency of the Global Design Quality function activities, generate measures and metrics to drive behaviour and continuous improvement.

Drive product risk management activities and lead mitigation assessments and implement in compliance with ISO 14971 and other applicable requirements.

Provide leadership and commitment to continually improve and maintain the effectiveness of the QMS to strengthen overall design controls and elevate the focus on exceeding our customer’s expectations

Engages, leads and collaborates with the sustaining engineering function in deploying new, or changes to existing, processes, products and systems to improve the overall customer satisfaction.

External Influence: 10%

Extensive understanding of FDA and global regulations and standards, including China, India, Brazil and other major countries/regions

Support external (regulatory & customer) audits for FDA, ISO 9001 and ISO 13485

Interact with and understand our internal and external customers’ expectations and needs

Communicate with external regulatory agencies as needed to ensure timely new product introduction globally.

Other Responsibilities: 25%

Complete Quality System related actions in a timely manner according to procedures e.g. CAPA, NCR, deviation, internal audit, external audit.

Adhere to Environmental, Health and Safety policies and procedures. Maintain an appropriate environment for the occupational health of employees.

Identify new, or changes to existing, processes and systems to improve effectivity and efficiency of the Quality system in accordance with the applicable requirements.

Other activities as need to best support the overall success of the business.

Lead direct reports through:

Setting objectives and monitoring their progress

Setting performance expectations and monitoring through regular communication, the performance review process and, where necessary, through the disciplinary process

Supporting development through development planning, feedback and coaching

Qualifications Bachelor’s degree required preferably in science or engineering. Advanced degree preferred

Significant experience in design quality assurance with a strong working knowledge of various Design Control processes as well as Software Development Life Cycle (SDLC) models and validation testing methodologies.

Demonstrated capability to lead, manage and drive change through a multi-disciplinary, geographically distributed team.

Design Quality experience with medical devices, IVD or Biotech industry, including hardware, software, consumables and accessories.

10+ years managerial experience

Proven knowledge of design and execution of processes compliant to ISO 9001, ISO 13485, ISO 14971, ISO 62304, 21 CFR 820, EU IVDR, 93/42/EEC and 98/79/EC as applicable.

Ability to manage and influence within a matrix organization

Highly developed intercultural competence/awareness

Key contacts:

VP Global Quality and Global Quality Management team

Global Products VP’s and Senior Directors

Global Quality personnel – Milford, Wexford, Wilmslow facilities.

Regulatory personnel.

Key Skills:

Strong leadership, coaching and mentoring skills.

Exceptional interpersonal and communication skills.

Demonstrate sound judgment/rationale and practical approach to problem solving.

Excellent report writing and reviewing skills.

Change Agent – drives continuous improvement / compliance to regulations.

Waters Employee Success Model Criteria

Operates with integrity, transparency and humility

Acts as a true company owner to advance the overall interests of Waters

Carries a broad global perspective of markets, tech, and trends

Balances clear strategic thinking and accountability in execution to deliver results

Actively creates the conditions for Waters’ people and teams to succeed

Company Description Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials and food sciences for 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.

Waters Corporation's businesses include Waters, TA Instruments, VICAM, ERA, and Nonlinear Dynamics.

Waters creates business advantages for laboratory-dependent organizations by delivering ultra performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry systems, laboratory informatics solutions, and comprehensive service programs to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.

Diversity and inclusion are fundamental to our core values at Waters Corporation. Celebrating diversity is important to us. We thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.

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Keywords: Waters Corporation, Milford , Sr. Director Global Design Quality, Other , Milford, Connecticut

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