Senior Supervisor, Quality Engineering

CooperCompanies•North Tonawanda, NY

9d•Onsite

About The Position

The Senior Supervisor, Quality Engineering is responsible for providing strategic oversight and leadership of Quality Management System (QMS) processes, including investigations, nonconformance management, CAPA, and compliance activities in accordance with applicable U.S. and international regulatory requirements (e.g., 21 CFR Parts 210, 211, 820, and ISO 13485). This role ensures consistent, compliant, and risk-based execution of quality processes through effective application of investigation methodologies, root cause analysis, and risk management principles, and is accountable for process quality, prioritization, escalation decisions, and inspection readiness, driving cross-functional alignment and continuous improvement to support product quality, regulatory compliance, and patient safety.

Requirements

Advanced knowledge of Quality Management Systems and oversight of investigations, complaints, nonconformances, and CAPA processes within regulated environments.
Strong risk assessment and decision-making capabilities, including the ability to evaluate data, assess impact, and determine appropriate escalation pathways.
Proven ability to review, approve, and defend quality records and decisions with strong scientific and regulatory rationale.
Demonstrated leadership and supervisory skills, including coaching, mentoring, and developing technical teams.
Strong cross-functional collaboration and communication skills.
Excellent analytical and problem-solving abilities, including trend identification and proactive risk mitigation.
Experience managing controlled documentation and electronic quality systems to ensure data integrity and inspection readiness.
Strong written communication skills with the ability to produce clear, concise, and audit-defensible documentation.
Effective organizational and prioritization skills to manage multiple quality processes and deadlines.
In-depth understanding of audit and inspection readiness and ability to support regulatory inspections.
Continuous improvement mindset with experience driving process enhancements.
5+ years of experience in the pharmaceutical, medical device, or combination product industry, with demonstrated responsibility for product complaint handling, post‑market surveillance, CAPA processes, and regulatory compliance within a regulated environment.
2+ years of oversight of complaint investigation activities, mentoring and coaching technical staff, workload prioritization, and accountability for investigation quality, timelines, and escalation decisions.
Bachelor’s degree in a Health, Engineering or Science field required.

Responsibilities

Provides strategic oversight of core Quality Management System processes, including investigations, complaints, CAPA, and audit observations, ensuring consistent application of risk-based methodologies and root cause analysis tools.
Reviews, triages, and assigns quality events to ensure appropriate prioritization and timely, compliant resolution, with consideration of product quality, patient safety, and regulatory risk.
Evaluates and approves investigation outcomes and associated risk assessments to determine the need for escalation such as CAPA, trend analysis, or regulatory reporting, ensuring risks are properly identified and mitigated.
Leads and facilitates cross-functional discussions and decision-making forums to drive timely issue resolution and alignment across Quality, Regulatory, Manufacturing, R&D, Supply Chain, and external partners.
Oversees verification of investigation conclusions and effectiveness of corrective and preventive actions through follow-up activities and effectiveness checks.
Coaches, mentors, and provides technical guidance to QA personnel to ensure consistent execution of quality processes and regulatory compliance.
Reviews and approves quality records (e.g., deviations, complaints, CAPAs) to ensure completeness, accuracy, and compliance with internal procedures and regulatory requirements.
Ensures maintenance of complete, accurate, and traceable quality system documentation within designated systems; monitors progress and drives timely escalation when needed.
Maintains inspection readiness by ensuring documentation is clear, objective, contemporaneous, and audit-ready.
Supports and contributes to regulatory actions as needed (e.g., responses to inspections, recalls, or field corrections).
Develops, reviews, and presents quality metrics and trending analyses to leadership to support oversight and continuous improvement initiatives.
Serves as a subject matter expert during internal and external audits and inspections related to QMS processes and regulatory compliance.
Drives continuous improvement of quality systems, processes, tools, and practices based on trends, audit findings, and evolving regulatory expectations.
Perform other duties as assigned.