Senior Quality Engineer

**About the Role**The Jackson Laboratory is seeking a Senior Quality Engineer to provide technical quality oversight throughout the product lifecycle, ensuring our products consistently meet customer and internal quality requirements. In this role, you will help develop and advance Quality Engineering practices across laboratory operations through batch record review and release, product disposition, documentation oversight, process validation, quality investigations, risk management, and continuous improvement initiatives.Partnering closely with Operations, Research & Development, Global Quality, and cross-functional teams, you will apply statistical analysis, Quality by Design (QbD) principles, Quality Risk Management (QRM), and data-driven decision-making to strengthen product quality, process robustness, data integrity, and regulatory compliance.**Location:** Farmington, CT (Hybrid) 2-3 days per week onsite **Salary Range:** $80,167 – $116,242 based on years of related experience and internal equity considerations**What You'll Contribute*** Establish and mature Quality Engineering practices, standards, and processes that support product quality, regulatory compliance, and operational excellence across laboratory and manufacturing operations.* Review, approve, and release batch records, manufacturing documentation, and quality records to support product disposition and ensure compliance with quality requirements.* Provide technical quality oversight throughout the product lifecycle, including development, technology transfer, manufacturing, product release, change management, and continued process verification.* Apply regulatory requirements and industry standards, including cGMP, FDA 21 CFR Parts 210, 211, and 11, and ICH guidelines (Q8, Q9, Q10).* Support and lead qualification and validation activities, including equipment qualification (IQ/OQ/PQ), process validation, analytical method qualification/validation, and validation lifecycle management.* Apply QbD, QRM, and statistical methodologies to improve process capability, product quality, and operational performance.* Lead quality investigations using structured root cause analysis methodologies (e.g., 5 Why, Fishbone) and drive effective CAPA implementation, effectiveness verification, and continuous improvement.* Review, approve, and provide quality oversight for change controls, deviations, specifications, procedures, protocols, and other controlled documents within the Quality Management System (QMS).* Lead and facilitate risk assessments using tools such as FMEA, Hazard Analysis, and Risk Ranking to support product disposition, process changes, validation activities, and business decisions.* Apply statistical analysis, including Statistical Process Control (SPC), process trending, and hypothesis testing, to identify improvement opportunities and support data-driven decisions.* Support internal audits, supplier audits, and inspection readiness activities.* Partner with Operations, R&D, Quality Control, and cross-functional teams to resolve quality issues, strengthen quality culture, standardize processes, and facilitate knowledge transfer. **What You Bring****Required Qualifications*** Bachelor's degree in Engineering, Biology, Chemistry, Microbiology, Biotechnology, Biomedical Engineering, Chemical Engineering, Quality Engineering, Life Sciences, or a related technical discipline (a combination of education and experience may be considered). Master’s degree would be a plus* 5+ years (8+preferred) of progressive experience in Quality Engineering, Quality Assurance, Manufacturing Quality, or Product Quality within a regulated biotechnology, pharmaceutical, medical device, or life sciences environment.* Demonstrated experience developing, implementing, and maturing Quality Engineering programs, processes, standards, and best practices in a regulated environment.* Experience providing quality oversight for GMP-regulated manufacturing or laboratory operations, including batch record review and release, product disposition, investigations, change control, process validation, and quality risk management.* Strong understanding of Quality Management Systems (QMS), Good Documentation Practices (GDP), ALCOA+ data integrity principles, cGMP, GLP, and applicable regulatory standards (e.g., FDA, ICH, ISO).* Experience supporting qualification and validation activities, including IQ/OQ/PQ, process validation, and analytical method qualification/validation.* Demonstrated ability to apply QbD, QRM, FMEA, and risk-based decision-making to improve product quality and process robustness.* Proficiency in statistical analysis and data-driven quality methodologies, including SPC, process capability analysis, hypothesis testing, trending, and Design of Experiments (DOE).* Proven experience leading cross-functional quality initiatives, influencing stakeholders without direct authority, and driving continuous improvement through Lean, Six Sigma, and quality system tools.* Experience developing quality metrics, monitoring KPIs, and analyzing trends to identify opportunities for improvement.* Experience supporting internal and external audits, supplier quality activities, regulatory inspections, deviation investigations, CAPA, and inspection readiness.* Strong technical writing, communication, and leadership skills, with the ability to mentor others, manage multiple priorities, and build a culture of quality excellence.* Ability to travel up to 20%.**Physical Demands:** Primarily sedentary; sitting most of the time with brief periods of standing or walking; occasional lifting up to 10 lbs. #J-18808-Ljbffr JAX