Quality Engineering Manager

Work Schedule

Standard (Mon-Fri)

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

fully onsite - Relocation assistance is NOT provided.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

• Manage and mentor a team of quality engineers and technicians, setting goals, providing guidance, driving ownership, accountability and fostering a culture of continuous improvement.

• Crafting personalized career development plans and performance reviews for each team member, finding opportunities, and defining individual goals to support these development plans.

• Ensure consistency with health and safety guidelines and legal obligations.

• Support in the development, execution, and upkeep of the site’s Quality Management System (QMS) and overall quality assurance strategy to align with organizational goals.

• Crafting new strategies to improve efficiency, elevate product quality, pinpoint process improvements, and adjust to the ever-changing business landscape while encouraging a culture of ongoing improvement and responsibility among team members.

• Understand customer needs and requirements to develop effective quality control processes that meet their needs.

• Oversee the quality deliverables for product development and incorporate manufacturability and quality standards into the design.

• Apply data analysis, Lean and Six Sigma methodologies, and deep-dive investigation to identify and address underlying issues to improve efficiency.

• Devise and review inspection specifications and plans for products or processes.

• Establish requirements for suppliers and monitor their consistency with these requirements.

• Be responsible for the Material Review Board (MRB) in reviewing, dispositioning and identifying corrective actions for non-conformance materials.

• Ensure products and processes align with applicable industry standards, regulations (e.g., ISO 9001 and ISO 13485), and customer specifications. This role requires supporting audits conducted both within the organization and by external parties.

• Collaborate with various departments, including engineering, manufacturing, product development, and supply chain, to ensure that quality standards are consistently upheld throughout.

• Support the investigation and resolution of blocking issues from customers and CAPA investigations.

• Minimum Required
  
  Education:
  
  Bachelor’s degree in a technical/scientific or related field

• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is desired

• Professional Certifications, such as Lean Manufacturing, Six Sigma (green or black belt), preferred

• Minimum 10 years of proven experience working in an ISO
  9001 or ISO
  13845 manufacturing environment required

• Minimum 5 years of managerial or supervisory experience required

• Knowledge of quality management systems like ISO 9001, ISO 14971, and ISO 13485, process control, and the technical skills needed for the company's products.

• Demonstrated history of leading, guiding, and motivating a technical team, showcasing strong communication, interpersonal abilities, and capacity for addressing challenges.

• Extensive understanding of quality assurance methodologies, manufacturing procedures, root cause analysis, and corrective measures.

• Proficient in project…