Sr. Manager, Quality Engineering

Abbott Laboratories•Lewes, DE

15h

About The Position

The Senior Manager, Quality Engineering provides enterprise‑level leadership across Quality Engineering and Compliance functions, ensuring the effectiveness, sustainability, and business integration of the Quality Management System (QMS). The role is accountable not only for regulatory compliance and product quality, but also for driving measurable business outcomes—including cost optimization, throughput improvement, and operational risk reduction—through data‑driven quality strategies. This role serves as a key quality leader influencing decisions across manufacturing, engineering, supply chain, and capital delivery functions, while advising executive leadership on quality performance, trends, and risk.

Requirements

Bachelor’s degree in engineering, Science, Quality, Regulatory Affairs, or related field (required).
10+ years progressive experience in regulated industries (Medical Devices, Diagnostics, Pharmaceuticals preferred).
Demonstrated success leading Quality organizations with enterprise or multi‑functional influence.
Strong understanding of FDA QMSR, ISO 13485, CAPA systems, audits, validations, and operational quality integration.
Proven ability to apply data‑driven quality strategies to improve cost, throughput, delivery performance, and risk outcomes.
Experience partnering with Operations, Engineering, Supply Chain, and Finance to balance compliance with business execution.
Strong change leadership capability with a track record of driving sustainable improvements.
High financial and commercial acumen; able to articulate the business value of quality decisions.
Effective leader in matrixed, global organizations.
Travel requirement: 10%.

Nice To Haves

Master’s Degree preferred.

Responsibilities

Provide strategic leadership for Quality Engineering, ensuring alignment between quality objectives, operational performance, and enterprise business priorities.
Establish and sustain an inspection‑ready QMS compliant with FDA QMSR (21 CFR 820), ISO 13485, and applicable global regulations.
Serve as senior quality representative and escalation point for regulatory inspections, external audits, and significant quality events.
Influence quality strategy across multiple functions and divisions, ensuring consistent application of standards, processes, and risk‑based decision making.
Define, monitor, and continuously improve enterprise quality metrics that link quality outcomes to cost, throughput, delivery, and operational risk.
Leverage trend analysis, leading indicators, and predictive quality metrics to proactively identify risks and improvement opportunities.
Translate quality data into clear executive‑level insights to support informed decision making, investment prioritization, and risk management.
Drive standardization, automation, and scalability of quality reporting and analytics systems.
Ensure product acceptance, release, and lifecycle quality activities fully comply with regulatory and internal requirements while enabling efficient operations.
Oversee nonconformance management, CAPA effectiveness, internal audits, and supplier quality performance as integrated risk controls.
Lead Quality Review Boards (QRBs) for Facilities, Utilities, Equipment, and Metrology to balance compliance rigor with operational efficiency.
Provide quality oversight and approval for Facilities, Utilities, Equipment, validation, commissioning, and lifecycle quality records.
Enable large capital projects and complex engineering initiatives by embedding quality requirements early and reducing downstream compliance risk.
Partner with Corporate Engineering and operational leaders to approve Quality Agreements, audit reports, and quality system changes across divisions.
Influence cross‑site and cross‑business alignment of quality practices to support scalability, global consistency, and execution speed.
Own preparation, execution, and continuous improvement of Executive Management Reviews (EMRs).
Present quality performance, trends, and strategic risks to executive leadership, including participation in Global Management Review (GMR) forums.
Ensure management reviews drive actionable outcomes, resource prioritization, and sustained system effectiveness.
Build and sustain a high‑performing Quality Engineering organization with strong technical depth, leadership capability, and succession readiness.
Hire, develop, and retain top talent; set clear expectations aligned with enterprise objectives and coach leaders to deliver results.
Champion a culture of continuous improvement, accountability, and proactive quality ownership.
Foster a safe, inclusive, and performance‑driven work environment.
Sponsor and support early‑career talent development programs, including college and high‑school internships.