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Thermo Fisher Scientific Quality Engineer III, Exceptions Management in Ward Hill, Massachusetts

Position Summary :

This position will be responsible for the oversight and management of several quality systems at the Thermo Fisher Scientific Ward Hill site. The Ward Hill site is ISO 9001:2015 registered and is part of the Laboratory Chemicals Division of Thermo Fisher. The successful candidate will be responsible for all aspects of these quality systems including the exception system, complaint coordination and investigations, CAPA program, KPI development/reporting, and some QMS and quality tool training. This role will serve as primary contact for site and external customers, driving timely closure of exception investigations and corrective actions on behalf of the Ward Hill team. Duties also include participating in internal and external audits, conducting FMEA assessments, and driving process improvement. Candidate must be an established quality system leader, strong communicator, and able to work with minimal direct oversight.

Job Responsibilities:

  • Manage the Complaint and CAPA Systems via Trackwise, which includes:

  • Review all complaint submissions via central inbox and coordinate investigation assignments with Technical Services, Operations, support teams

  • Track and report status and metrics to ensure timely and effective closure

  • Outline CAPA plans and verify effectiveness of completed CAPAs

  • Act as primary liaison with customers and internal support groups to meet related customer documentation and closure requirements

  • Serve as site investigation lead and SME by developing and providing training on investigative tools such as 5-Whys, fishbone diagrams, and brainstorming

  • Partner with Operations to co-lead complex and priority investigation and process improvement related initiatives and forums

  • Co-lead customer and ISO 9001 related registrar audits including coordinating preparation activities, SME interviews, and response preparation

  • Lead/participate in site process improvement projects (PPI/Lean) and QMS related projects to address deficiencies, foster system enhancement, or compliance to corporate requirements

  • Collaborate with the Sales team in support of high-priority customer projects ensuring quality requirements are met, product specifications are in place, and any special product or supply chain requirements are clearly delineated and implemented.

  • Update and develop procedures and work instructions, as necessary to ensure conformance with ISO 9001.

  • Perform other duties as assigned

Essential Skills and Experience:

  • Proficient knowledge of Quality Management Systems particularly with complaint, exception, and CAPA systems in accordance with ISO 9001: 2015 and/or GMP standards.

  • Adept with risk-based thinking and ability to assess issues, identify critical data/information required, and recommend next course of action.

  • Skilled at Key Performance Indicator (KPI) development, trending, and site-based reporting to demonstrate performance and improvement opportunity areas

  • Ability to manage numerous priorities and activities in parallel (project management)

  • Strong collaborative and “people skills” to be able to deal with various personalities and levels within and outside of the organization

  • Excellent written and verbal communication skills

  • Excellent organizational skills and must be detail oriented.

Education

  • Bachelor’s Degree in Chemistry, Biology, Engineering, or equivalent

Experience

  • At least 5 years of experience with Quality in an ISO 9001/GMP regulated manufacturing environment with 2 years of experience as functional lead/SME of complaints, exceptions, or CAPA system

  • Experience with QMS software such as Trackwise, Agile, SuccessFactors, or MasterControl preferred

  • PPI/OEx-Lean production system experience

  • Proven track record of hands-on problem-solving expertise in a manufacturing environment.

  • Proficiency of Excel, Word, PowerPoint, including data analysis and statistical methods.

  • Strong communication skills and ability to present to various levels of internal and external stakeholders.

  • Strong technical writing skills for investigations, quality policies, and/or technical postiions

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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