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. 

This position is based onsite in Danvers, MA. We believe in the value of in-person collaboration and operate with a minimum 5-day-per-week onsite schedule to support innovation, learning, and cross-functional partnership. 

Key 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. 

Required 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