Quality Engineering Manager at Thermo Fisher Scientific

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

NoVisa

Life Sciences, Biotechnology, ManufacturingIndustries

Requirements

Bachelor’s degree in a technical/scientific or related field
ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) 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 13485 manufacturing environment
Minimum 5 years of managerial or supervisory experience
Knowledge of quality management systems like ISO 9001, ISO 14971, and ISO 13485, process control, and technical skills for the company's products
Demonstrated history of leading, guiding, and motivating a technical team with strong communication and interpersonal skills
Legally authorized to work in the United States without sponsorship
Able to pass a comprehensive background check, including drug screening
Able to lift 40 lbs. without assistance; adherence to GMP safety standards; able to work in office with some PPE required

Responsibilities

Manage and mentor a team of quality engineers and technicians, setting goals, providing guidance, driving ownership, accountability, and fostering continuous improvement
Craft personalized career development plans and performance reviews for team members, identifying opportunities and defining individual goals
Ensure consistency with health and safety guidelines and legal obligations
Support development, execution, and upkeep of the site’s Quality Management System (QMS) and overall quality assurance strategy aligned with organizational goals
Develop new strategies to improve efficiency, elevate product quality, identify process improvements, and adapt to business changes while encouraging continuous improvement
Understand customer needs to develop effective quality control processes
Oversee quality deliverables for product development, incorporating manufacturability and quality standards into design
Apply data analysis, Lean, and Six Sigma methodologies for root cause investigations to improve efficiency
Devise and review inspection specifications and plans for products or processes
Establish supplier requirements and monitor compliance
Lead Material Review Board (MRB) for reviewing, dispositioning, and identifying corrective actions for non-conformance materials
Ensure products and processes comply with industry standards, regulations (e.g., ISO 9001, ISO 13485), and customer specifications; support internal and external audits
Collaborate with engineering, manufacturing, product development, and supply chain to uphold quality standards
Support investigation and resolution of customer blocking issues and CAPA investigations

Skills

Key technologies and capabilities for this role

Quality Management SystemQMSTeam LeadershipMentoringPerformance ReviewsCareer DevelopmentGMPHealth and SafetyQuality AssuranceProcess ImprovementQuality Control

Questions & Answers

Common questions about this position

Is this role remote or onsite?

The position is fully onsite in Santa Clara, CA.

What are the key responsibilities of the Quality Engineering Manager?

The role involves managing and mentoring a team of quality engineers and technicians, developing and executing the Quality Management System, applying Lean and Six Sigma for process improvements, ensuring compliance with standards like ISO 9001 and ISO 13485, and collaborating cross-functionally.

What is the company culture like at Thermo Fisher Scientific?

The culture empowers employee development, fosters continuous improvement and accountability, and provides resources for growth with the largest R&D investment in the industry.

What are the physical and environmental requirements for this job?

The role requires ability to lift 40 lbs. without assistance, adherence to GMP safety standards, office work, and some PPE including safety glasses, gowning, gloves, lab coat, and ear plugs.

What qualifications or requirements are needed to apply?

Candidates must be legally authorized to work in the US without sponsorship and able to pass a comprehensive background check including drug screening; experience in team management, QMS, Lean/Six Sigma, and compliance with ISO standards like 9001 and 13485 would make a strong candidate.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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