Senior Quality Engineer

CooperCompanies•North Tonawanda, NY

10h•Onsite

About The Position

The Quality Engineer Sr is responsible for owning the Change Control program and providing QA oversight of validation, equipment lifecycle management, and risk management systems. This role ensures compliance with FDA regulations and current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210, 211, applicable elements of 21 CFR Part 820, and relevant ISO standards (e.g., ISO 13485), while embedding risk-based thinking across all quality system processes and site operations, and leads the application of formal risk management principles across the Quality Management System (QMS), ensuring business decisions, process improvements, and quality actions are prioritized, justified, and executed based on scientific, data-driven risk assessment. The Quality Engineer Sr provides site-wide leadership in risk-based quality engineering, with primary accountability for the Change Control program, QA oversight of validation and equipment management, and the integration of risk management into all quality and operational processes at the North Tonawanda, NY facility. This role ensures that all changes, validation activities, and quality systems are executed using robust risk assessment methodologies, enabling compliant, efficient, and inspection-ready operations, and works extensively with cross-functional teams to support new and improved processes, ensuring that risks are proactively identified, evaluated, controlled, and continuously monitored. This role also leads and supports supplier quality, investigations, CAPA, audit response, and inspection readiness, while contributing to site training and quality culture development.

Requirements

Advanced expertise in risk management methodologies (e.g., FMEA, hazard analysis, risk ranking tools) and their application in regulated environments.
Strong experience applying ICH Q9 risk management principles within a pharmaceutical or medical device QMS.
Proven ability to lead risk-based decision making across multiple quality systems.
Advanced knowledge of Change Control ownership and governance.
Deep understanding of validation and equipment lifecycle risk management.
Extensive experience in investigations, CAPA, and root cause analysis with risk prioritization.
Experience supporting or leading regulatory inspections and audit responses.
Strong understanding of FDA (21 CFR 210/211/820) and ISO standards (ISO 13485).
Ability to influence cross-functional stakeholders using data-driven risk insights.
Excellent analytical, communication, and leadership skills.
Ability to operate as the senior QA engineering authority onsite.
5+ years experience working in regulated manufacturing environment preferably within pharmaceutical or medical device related field.
Significant experience leading risk-based quality systems, Change Control, and validation oversight.
Demonstrated role as a senior or lead QA professional.
Bachelor’s degree in a Health, Engineering or Science field, or associate’s degree with 5+ years of relevant experience, or high school diploma with 10+ years of relevant experience required.

Nice To Haves

Advanced degree preferred.

Responsibilities

Own and govern the site Change Control program, ensuring all changes are initiated, risk-assessed, approved, implemented, and closed in compliance with regulatory and internal requirements; drive continuous improvement in effectiveness, cycle time, and compliance metrics.
Lead and embed risk management practices across the site, applying ICH Q9 principles to Change Control, validation, investigations, CAPA, and supplier quality; facilitate formal risk assessments (e.g., FMEA), ensure risk-based decision-making, and proactively identify and mitigate systemic risks.
Provide QA oversight for validation and equipment lifecycle management, including equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and CSV; ensure all activities are risk-based, compliant, and aligned with cGMP and data integrity requirements.
Partner cross-functionally with Engineering, Manufacturing, Validation, Regulatory, Supply Chain, and other stakeholders to support new and improved processes, ensuring quality-by-design and risk-based principles are embedded in process design, changes, and technology transfers.
Perform complex investigations and CAPA, ensuring robust root cause analysis, risk prioritization, and implementation of effective, sustainable corrective and preventive actions that address systemic issues.
Support the site supplier quality program, including supplier-related investigations, CAPA, change evaluations, risk assessments, and audit follow-up activities to ensure supplier compliance and performance.
Support audit and inspection activities, including internal, supplier, and regulatory audits; serve as a key QA representative during inspections, ensure effective response to audit observations, and maintain a continuous state of inspection readiness.
Review and approve complex quality documentation, ensuring accuracy, completeness, and compliance with cGMP and data integrity standards.
Support site training initiatives and quality culture development, including training on Change Control, validation, and risk-based quality systems; provide mentorship and technical guidance to cross-functional teams.
Serve as site SME for Change Control, validation oversight, equipment quality systems, and risk management, influencing quality strategy and decision-making at all levels.
Perform other duties as assigned.