Sr Manager, Product Quality

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

DESCRIPTION:

When your part of the team at Thermo Fisher Scientific, you'll do important work. As we continue to grow, you'll have career advancement opportunities and learning in a culture that empowers your development. We give our people the resources and opportunities to make significant contributions to the world. Now is an exciting time to join our Quality team! We are dedicated to ensuring our customers receive the products they need to achieve their scientific goals quickly and safely.

Position Summary:

The Sr Manager, Product Quality Life Science Mass Spectrometry (LSMS) is responsible for providing support and leadership to the whole Business Unit. The Product Quality function is responsible for the for coordinating and driving Quality improvements across all sites and with our suppliers. As well as ensuring these improvements drive the warranty cost reduction for the Business Unit, with our service team, product support team and suppliers.

Key Responsibilities:

• Fosters a quality culture to achieve program success through measurable activity, metrics, and strong ability to influence teams in the areas of focus.

• Lead and inspire a strong product quality team by hiring and developing strong product quality personnel, establishing, and actively managing performance expectations, and providing development and training opportunities.

• Coach and motivate product quality with a mix of (ISO 9001), CE- IVD (13485), and GMP (21CFR820) products.

• Manages multiple areas responsible for product quality.

• Drives consistent adoption of Quality Tools across the Business Unit, including 8D Corrective Action, Error Proofing, Failure Modes and Effects Analysis (FMEA), Design for Manufacturability (DFM), FAIRS/PPAP, Statistical Process Control (SPC), Design Validation and Process Validation testing (DVT/PVT), and Critical to Quality (CTQ) documentation.

• Impacts product quality for assigned products, working with Operations, Quality, R&D, Service and Product Support teams affecting warranty costs, instrument installations, and customer allegiance.

• Determines priorities for projects regarding maintenance and improvement of Business Unit specific systems; recommends priorities and actions for those controlled by outside resources (such as division or corporate IT systems) affecting the local product quality.

• Has the necessary independence and authority within the area, and through reporting relationships to initiate actions as needed to ensure the quality, safety and efficacy of all products.

• Other miscellaneous duties as assigned.

REQUIREMENTS:

Minimum Requirements/Qualifications:

• Bachelor's degree in engineering or related scientific discipline; MBA or advanced engineering or scientific degree is preferred.

• Minimum 10 years' experience in Quality Assurance management and leadership, preferably in Medical Device environment.

• Minimum 3 years in a Quality Leadership Role in a medical device company or other highly regulated industry such as aerospace or automotive. Experience in a startup environment is a plus.

• Strong project leadership capability and ability to drive culture change. Working knowledge of ISO requirements. Experience working in a six sigma or TQM manufacturing environment.

• Proven experience in using data and statistical techniques to drive continuous improvements.

• Extensive knowledge and experience in validation process design and process validation, change control, and auditing quality management systems.

• Experience working with a broad range of people from manufacturing personnel to senior management.

• Experience in product development software and hardware quality systems and audits.

• Must exhibit strong personal moral and ethics code, proactive, overall positive personality, and creativity in solving various complex situations in technical and social areas.

• Must demonstrate good communications skills and be able to work effectively with cross- functional teams on projects including international and multicultural teams and suppliers and customers.

• Must demonstrate fluent English - both in speech and writing.
• Ability to travel up to 25%