Staff QA Engineer

Thermo Fisher Scientific - Tewksbury, MA

Full-time - Mid Level

Tewksbury, MA

Computer and Electronic Product Manufacturing

About the position

As part of the Thermo Fisher Scientific team, the Staff QA Engineer will play a crucial role in enhancing the quality management system (QMS) tools and processes within the Chemical Analysis Division (CAD). This position is pivotal in ensuring that quality and regulatory requirements are met comprehensively, particularly in the battery market. The Staff QA Engineer will be responsible for overseeing the validation of all sourcing and engineering changes, as well as providing support for the New Product Development and Introduction (NPDI) process for all battery manufacturing customers. This role involves quality planning for New Product Introductions, facilitating design transfers to manufacturing, and sustaining activities for current products. The Staff QA Engineer will also conduct QMS training, perform risk assessments, develop Failure Mode and Effects Analyses (FMEAs), compile 8D reports, manage Corrective and Preventive Actions (CAPA), conduct internal audits, and engage in data analytics to drive quality improvements. In this role, the Staff QA Engineer will lead the implementation of QMS tools and process upgrades, including 8D, PFMEA, Document Control, Control Plans, and Change Control. They will investigate product and process failures, collecting relevant information for Failure Analysis and communicating findings to both internal and external customers. The Staff QA Engineer will drive CAPA actions with urgency, ensuring timely closure and effective monitoring of engineering change orders. They will also lead the change control process for all product and service aspects, ensuring that validation processes are thoroughly documented and compliant with applicable standards. Additionally, the Staff QA Engineer will establish product quality control plans, monitor product metrics, and lead business unit Product Quality reviews while acting as a coach and mentor for quality systems. They will manage NPDI Quality activities, ensuring timely execution and successful transitions of new or modified products into manufacturing. Continuous improvement projects will also be championed or supported as needed.

Responsibilities

• 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, including assigning appropriate actions for containment and monitoring effectiveness of engineering change orders.
• 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 control plans; monitor and report on product metrics.
• Lead 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.

Requirements

• Bachelor's degree required, preferably in a technical/scientific or related field such as engineering, chemistry, biology, or mathematics.
• At least 5 years of experience in the 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.
• Expert level knowledge of ISO 9001 required; IATF 16949 knowledge preferred.
• Solid understanding of 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.

Nice-to-haves

• Experience in the battery manufacturing sector.
• Familiarity with regulatory requirements specific to the battery market.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Career and development prospects
• Innovative and forward-thinking organization
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.