Senior Quality Engineering Manager

Job Summary The Senior Quality Engineering Manager is responsible for leading the team of quality engineers supporting manufacturing operations. The Quality Engineering team scope spans the areas of change management, nonconformance management, and late-stage development deliverables as projects move from design stage to commercial launch. The incumbent ensures the consistent delivery of devices that meet customer specifications by driving accountability to quality KPIs and monitoring quality system compliance and health. They also provide tactical leadership of the QE team by giving guidance on prioritization and handling escalations, fostering effective cross-functional collaboration, and developing each engineer’s skill set to further their growth as a quality professional.   Job Duties and Responsibilities Team Leadership & Talent Development People Management: 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. Maintain a high level of technical fluency, remaining willing to provide hands-on support for customers and deliverables. 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)   Working Conditions On-site office and manufacturing environment