Senior Quality Engineer

About the role

In this role, you'll partner across Engineering, Manufacturing, Operations, and Quality teams to develop and maintain robust quality systems, drive continuous improvement initiatives, and ensure products and processes consistently meet regulatory, customer, and business requirements. You'll leverage technical expertise, data-driven decision-making, and cross-functional collaboration to solve complex quality challenges and help deliver safe, effective products to market.

Responsibilities

• Lead the development, implementation, and maintenance of quality standards, processes, and protocols across manufacturing and product development activities.
• Partner closely with Manufacturing, Operations, R&D, and Process Engineering teams to ensure quality requirements are integrated into products and processes.
• Develop and execute inspection, testing, validation, and monitoring strategies to ensure compliance with quality and regulatory requirements.
• Design, specify, and evaluate inspection and testing methods, equipment, and measurement systems to support product quality and process performance.
• Analyze quality data, identify trends, and utilize statistical techniques to drive root cause investigations, risk mitigation, and continuous improvement initiatives.
• Lead investigations related to nonconforming materials, products, and processes, ensuring effective corrective and preventive actions are implemented.
• Support and drive CAPA, nonconformance, complaint, audit, and risk management activities.
• Ensure quality documentation, records, and processes comply with applicable regulatory requirements, quality system standards, and internal procedures.
• Collaborate on new product development, product transfers, process validations, and manufacturing improvements to ensure quality is built into every stage of the product lifecycle.
• Mentor and provide technical guidance to engineers and cross-functional teams on quality principles, tools, and best practices.
• Drive initiatives that improve product reliability, manufacturing efficiency, and overall quality system effectiveness.

Requirements

• Must Have:
  • Bachelor’s Degree and Minimum of 4 years of relevant experience OR Advanced degree with a minimum of 2 years relevant experience
• Preferred:
  • Experience in medical device or other FDA regulated manufacturing environments.
  • Strong understanding of quality systems, risk management, validation, CAPA, nonconformance management, and regulatory requirements.
  • Experience supporting manufacturing operations and cross-functional engineering teams.
  • Proficiency with statistical analysis, problem-solving methodologies, and continuous improvement tools.
  • Knowledge of FDA Quality System Regulations, ISO 13485, and other applicable regulatory standards.
  • Strong communication, collaboration, and project leadership skills.
  • ASQ Certified Quality Engineer (CQE) or equivalent certification is a plus.

Qualifications

• Must Have:
  • Bachelor’s Degree and Minimum of 4 years of relevant experience OR Advanced degree with a minimum of 2 years relevant experience
• Preferred:
  • Experience in medical device or other FDA regulated manufacturing environments.
  • Strong understanding of quality systems, risk management, validation, CAPA, nonconformance management, and regulatory requirements.
  • Experience supporting manufacturing operations and cross-functional engineering teams.
  • Proficiency with statistical analysis, problem-solving methodologies, and continuous improvement tools.
  • Knowledge of FDA Quality System Regulations, ISO 13485, and other applicable regulatory standards.
  • Strong communication, collaboration, and project leadership skills.
  • ASQ Certified Quality Engineer (CQE) or equivalent certification is a plus.

Skills

• Technical expertise
• Data-driven decision-making
• Cross-functional collaboration
• Statistical analysis
• Problem-solving methodologies
• Continuous improvement tools
• Quality systems
• Risk management
• Validation
• CAPA
• Nonconformance management
• Regulatory requirements
• Communication
• Collaboration
• Project leadership
• Quality principles
• Tools
• Best practices

Benefits

Competitive Salary and flexible Benefits Package including Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).