Staff QA Engineer

Thermo Fisher Scientific - Tewksbury, MA

Full-time - Mid Level

Tewksbury, MA

Computer and Electronic Product Manufacturing

About the position

The Staff QA Engineer at Thermo Fisher Scientific is responsible for implementing Quality Management System (QMS) tools and process upgrades within the Chemical Analysis Division. This role focuses on ensuring quality and regulatory compliance for the battery market, overseeing the validation of sourcing and engineering changes, and supporting New Product Development and Introduction (NPDI) processes. The position involves quality planning, risk assessments, training, and data analytics to enhance product quality and customer satisfaction.

Responsibilities

• Lead implementation of QMS Tools and process upgrades such as 8D, PFMEA, Document Control, Control Plans, and Change Control.
• Conduct investigations on product/process failures and communicate findings to internal and external customers.
• Drive Corrective and Preventive Actions (CAPA) with intensity and ensure timely closure.
• Manage the change control process for products and services, ensuring validation processes are documented and compliant with standards.
• Facilitate the development and maintenance of process and design FMEAs.
• Establish product quality control plans and monitor product metrics.
• Lead business unit Product Quality reviews and mentor quality systems.
• Manage NPDI Quality activities and ensure timely execution of quality workstreams.
• Support continuous improvement projects as needed.

Requirements

• Bachelor's degree in a technical/scientific field such as engineering, chemistry, biology, or mathematics.
• At least 5 years of experience in the quality profession with a focus on implementing quality initiatives.
• Experience leading teams through problem-solving and using Root Cause Analysis (RCA) tools.
• Strong experience in developing, training, and coaching teams.
• Experience managing QMS programs including CAPAs, Change Control, Audits, and Risk Management.
• Expert level knowledge of ISO 9001; knowledge of IATF 16949 is preferred.
• Solid understanding of quality tools such as 8Ds, A3, CAPA, Customer Complaints, D/PFMEA, Statistical Process Control, and PPAP.

Nice-to-haves

• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is beneficial.
• Initiative and self-direction in planning, organizing, documenting, and solving problems.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Career and development prospects
• Innovative company culture that values integrity, intensity, involvement, and innovation.