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Staff QA Engineer

2 months ago

Tewksbury, United States Thermo Fisher Scientific Full time

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOffice, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Location/Division Specific InformationThe Chemical Analysis Division (CAD) provides a diverse mix of analytical instruments and associated services to a broad range of end user markets including Safety & Security, Environmental, Food Safety, Energy, Mining, Life Science Manufacturing and Recycling, to name a few. Its instruments are deployed in the field and on the line, in challenging environments where customers put a premium on robustness, reliability and ease of use. They allow them to make decisions where they operate and streamline their businesses. CAD is a complex division with a global footprint, broad product portfolio and diverse customer base.Discover Impactful Work:The Staff QA Engineer will have primary responsibility to roll out QMS tool and process upgrades within the division to better serve customer and regulator needs of the battery market. This role will ensure quality and regulatory requirements are met end to end, as well as validation for all sourcing and engineering changes, and NPDI process support for all battery manufacturing customers. This is achieved through quality planning for New Product Introductions, design transfer to manufacturing, and sustaining activities of current products. Additional responsibilities include QMS trainings, risk assessments, development of FMEAs, compilation of 8D reports, CAPA management support, internal audits and data analytics. This role will be reporting into Sr. Quality Manager of Strategic Programs.A Day in the Life:Lead implementation of QMS Tools and process upgrades - 8D, PFMEA, Document Control, Control Plans, Change Control etc.Lead investigations on product/process failures collecting all applicable information for Failure Analysis and communicate findings with internal and external customers.Drive CAPA actions with Intensity and ensure timely closure. This involves assigning appropriate actions for containment, monitoring effectiveness of engineering change orders, and coordinate agreed upon communications.Lead the change control process for all aspects of products and services, ensuring validation processes are fully documented and aligned with applicable standards.Facilitate development and maintenance of process and design FMEAs,Establish product quality controls plans; monitor, and report on product metricsLead business unit Product Quality reviews and act as coach and mentor for quality systems.Lead NPDI Quality activities, including management of quality workstream and ensuring timely execution.Ensure successful transitions of new or changed products into manufacturing.Champion or support continuous improvement projects where needed.Keys to Success:EducationBachelor's degree required. Preferably in technical/scientific or related field, e.g. engineering, chemistry, biology, or mathematics.ExperienceAt least 5 years of experience Quality profession with extensive experience implementing quality initiatives required.Experience leading teams through problem solving and use of RCA tools required.Strong experience in developing, training and coaching teams required.Managing QMS programs including CAPAs, Change Control, Audits and Risk Management required.Knowledge, Skills, AbilitiesExpert level knowledge of ISO 9001 required; IATF 16949 knowledge preferred. Solid understanding on the standard suite of quality tools, such as 8Ds, A3, Corrective and Preventive Actions, Customer Complaints, Failure Mode and Effects Analysis (D/PFMEA), Statistical Process Control and Production Part Approval Plans (PPAP).Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) beneficial.Initiative and self-direction in planning, organizing, documenting and solving problems..BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation