Senior Quality Engineering Manager

Job Duties And Responsibilities

• Team Leadership & Talent Development
• Directly supervise a team of quality engineers; manage workload distribution, conduct performance reviews, and establish clear accountability for individual and team goals.
• Coaching & Mentoring: Architect professional development plans for the QE team, focusing on technical skill building (e.g., risk-based thinking, root cause analysis) and “soft skills” (e.g., conflict resolution, cross-functional collaboration).
• Prioritization & Escalation: Serve as the primary point of contact for escalations within quality engineering, providing support for customer interactions and tactical guidance to ensure production hurdles are cleared without compromising quality.
• Quality System Oversight & Compliance
• KPI Management: Define, monitor, and report on quality key performance indicators (KPIs) indicating quality system process health. Analyze technical data to identify continuous improvement opportunities.
• Compliance Leadership: Maintain the health of the Quality Management System (QMS) in accordance with FDA 21 CFR 820 and ISO 13485, ensuring that the site is always in a state of audit readiness.
• Audit Representation: Act as a subject matter expert (SME) and spokesperson for Quality Engineering as needed during internal audits and external regulatory inspections.
• Manufacturing Operations Support
• Nonconformance Management: Oversee nonconforming material processes from material receiving through final device inspection, ensuring that nonconformances are investigated thoroughly, root causes are identified, and dispositions are risk assessed and justified.
• Change Control: Direct the quality review of engineering change orders (ECOs) and deviation authorizations (DAs) ensuring that permanent and temporary changes to processes, components, and/or equipment are appropriately evaluated, controlled, and documented.
• New Product Transfer & Late-Stage Development
• Design Transfer: Supervise the QE team through the transition of products from R&D to commercial manufacturing, ensuring that design transfer deliverables—including inspection methods and production controls—are robust.
• Cross-Functional Collaboration & Strategy
• Strategic Relationship Management: Communicate effectively with senior leadership regarding quality risks and resource needs; collaborate with Production, Supply Chain, and Engineering heads to align on business priorities.
• Process Improvement: Champion a culture of continuous improvement by deploying Lean and Six Sigma tools to streamline quality processes.
• Startup Agility: Adapt quality workflows to suit a fast-paced, evolving business environment while maintaining regulatory compliance and ensuring patient safety.

Requirements

• Bachelor’s degree in an engineering, a technical, or a scientific discipline
• 10+ years of relevant experience including quality assurance, quality control, and/or quality systems in a manufacturing environment; preferred: experience as a quality professional in a medical device–manufacturing firm
• Experience effectively managing direct reports, including team upskilling through coaching and mentoring and promoting a culture of accountability
• Strong leadership skills: clear communication, detail orientation, critical thinking, and confident decision making
• Experience navigating a business experiencing rapid change (e.g., startups, acquisitions)
• Relationship management: Proven capability to manage up, develop customer relationships, and drive team engagement
• Experience with regulated environments (e.g., FDA 21CFR 820, ISO 13485:2016, and ISO 9001:2015)
• Proficiency in quality improvement tools and techniques
• Fluent user of standard business tools (e.g., Outlook, Word, PowerPoint, Excel, Visio)