Staff Quality Engineer

Quick Facts

Staff Quality Engineer

Description

Provide quality leadership and oversight for manufacturing processes and product quality. Own and drive investigations, nonconformances (NCs), corrective and preventive actions (CAPAs), and root cause analysis activities.

Responsibilities

• Provide quality leadership and oversight for manufacturing processes and product quality
• Own and drive investigations, nonconformances (NCs), corrective and preventive actions (CAPAs), and root cause analysis activities
• Partner with Operations, Engineering, Supply Chain, and cross-functional teams to provide quality oversight and direction while ensuring compliance with ISO 13485, GMP, regulatory requirements, and quality systems
• Lead resolution of internal and supplier-driven nonconformances, including timely containment, root cause analysis, CAPA development, and effective closure
• Dispose nonconforming products through Material Review Board (MRB) processes; issue nonconformances as appropriate; support product holds, potential product escapes, and quality risk mitigation
• Serve as a subject matter expert in risk management, CAPA, change management, concession management, validation, statistical techniques, inspection methods, sampling plans, process capability, and quality system requirements
• Develop, assess, and approve quality-related changes, concessions, and risk management activities using data-driven decision making
• Analyze quality metrics and KPI trends, identify improvement opportunities, and implement corrective actions
• Lead and support local and global quality initiatives using Lean, Six Sigma, Human Error Prevention, and risk-based methodologies
• Optimize inspection methods, statistical sampling approaches, and process controls to ensure product quality, process capability, and compliance
• Participate in and lead internal, external, customer, supplier, and regulatory audits (preparation, response development, coordination, and engagement)
• Support validation strategies, execution, and approval while ensuring compliance with quality and regulatory requirements
• Lead or support manufacturing transfers, process changes, and product launches across facilities while maintaining quality objectives and regulatory requirements
• Manage supplier quality relationships (performance monitoring, issue resolution, nonconformance management, corrective actions, continuous improvement)
• Coach and mentor quality professionals and cross-functional teams on quality systems, risk management, CAPA, problem-solving, and regulatory compliance
• Represent Quality on local, global, and corporate review boards with expert guidance and recommendations

Requirements

• Bachelor’s degree in engineering, Quality, Life Sciences, Regulatory Affairs, or related technical discipline
• 4+ years of experience in Quality Engineering, Quality Assurance, or Regulatory Affairs within a regulated industry (medical device experience preferred)
• Strong understanding of medical device manufacturing processes, ISO 13485, GMP, and quality system requirements
• Expertise in CAPA, Risk Management, Root Cause Analysis, Audits, Validation, and Statistical Methods
• Experience with risk-based methodologies and statistical techniques (Process Risk Assessments, Statistical Sampling Plans, Process Capability Analysis, Gauge R&R)
• Strong analytical, problem-solving, critical thinking, and decision-making skills with exceptional attention to detail
• Ability to communicate effectively across the organization and influence cross-functional stakeholders
• Proven ability to lead quality initiatives and mentor others to drive compliance
• Self-starter who can manage multiple priorities in a fast-paced manufacturing environment
• Strong interpersonal skills, conflict resolution, and relationship-building with a customer-focused approach

Benefits

Health benefits include: medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.