Engineer II, QA
Thermo Fisher Scientific
Summary
The Quality Engineer II provides quality engineering support for bioprocessing equipment automation products, manufacturing and quality systems, ensuring products and processes consistently meet customer, regulatory, and business requirements. This role contributes to operational excellence by supporting validation and qualification activities, design control processes, quality investigations, and continuous improvement initiatives that enhance product quality, compliance, and manufacturing performance. The position ensures compliance with cGMP, ISO, FDA, and applicable quality standards while partnering with cross-functional teams to maintain audit readiness and support the business' quality objectives.
Job description
Day In The Life
Quality Systems & Compliance
- Support CAPA, nonconformance, deviation, and change control activities to ensure timely resolution and regulatory compliance.
- Review quality documentation to verify accuracy, completeness, and compliance with quality system requirements.
- Support document control activities and maintain quality records in accordance with established procedures.
- Assist with internal audits, customer audits, and regulatory inspections.
- Support implementation of corrective and preventive actions to improve product and process quality.
Validation, Qualification & Design Quality
- Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for equipment, systems, and manufacturing processes.
- Review and approve validation protocols, qualification reports, and related documentation.
- Participate in design reviews, design verification, design validation, and design change activities.
- Support risk assessments using FMEA and other quality engineering methodologies.
- Evaluate equipment, process, and product designs for compliance, manufacturability, reliability, and quality requirements.
Investigation & Continuous Improvement
- Lead or support investigations involving product, process, supplier, and customer quality issues.
- Perform root cause analysis using structured problem-solving methodologies such as Fishbone, 8D, and FMEA.
- Analyze quality metrics and trends to identify opportunities for continuous improvement.
- Support implementation and verification of corrective and preventive actions.
- Participate in projects that improve product quality, compliance, and operational efficiency.
Cross-Functional Collaboration & Customer Support
- Partner with Engineering, Manufacturing, Validation, Supply Chain, Regulatory Affairs, and Operations teams to resolve quality issues.
- Provide quality support for equipment, process, and product changes throughout the product lifecycle.
- Support customer complaint investigations and supplier quality activities.
- Communicate quality risks, investigation findings, and recommendations to stakeholders.
- Perform other duties and responsibilities as assigned to support business objectives, quality initiatives, and operational requirements.
Requirements
- Advanced degree in Engineering, Life Sciences, Chemistry, Biotechnology, or related technical field with no prior professional experience OR Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology, or related technical field with two years of experience in quality assurance, quality engineering, or quality systems within GMP/ISO-regulated environments, preferably medical device, pharmaceutical, biotechnology, or bioprocessing industries.
- Experience supporting quality systems including CAPA, deviations, nonconformances, change control, and investigations.
- Experience supporting equipment, process, or system qualification and validation activities.
- Experience collaborating with cross-functional engineering and manufacturing teams.
- Knowledge of cGMP regulations, ISO 13485, 21 CFR Part 820, validation requirements, and applicable quality standards.
- Understanding of quality systems including CAPA, deviations, nonconformance management, change control, and customer complaint handling.
- Knowledge of design control principles, design verification, design validation, and risk management processes.
- Experience supporting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Knowledge of quality engineering tools including FMEA, Fishbone, 8D, root cause analysis, and statistical quality methodologies.
- Strong analytical and problem-solving skills with the ability to evaluate quality data and recommend improvements.
- Excellent technical writing skills for SOPs, validation protocols, qualification reports, investigation reports, and technical documentation.
- Proficiency with Microsoft Office applications and quality management systems such as TrackWise, SAP QM, or equivalent.
- Strong organizational, project management, and prioritization skills.
- Excellent verbal and written communication skills with the ability to collaborate effectively across Engineering, Manufacturing, Supply Chain, Validation, Regulatory Affairs, and Operations.
- Ability to work independently while contributing effectively within cross-functional teams.
- Strong attention to detail and commitment to quality and compliance.
- 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.
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.