Senior Quality Engineer

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 require a minimum 5‑day‑per‑week onsite schedule.

• 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.

• Bachelor’s Degree and minimum of 4 years of relevant experience.
• Advanced degree with a minimum of 2 years of relevant experience.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

• 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.

The above statements describe the general nature and level of work being performed and are not exhaustive. The physical demands described within the Responsibilities section are representative of those required to successfully perform the essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. For Office Roles:
The employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co‑workers. Contact your manager or local HR to understand the work conditions and physical requirements specific to this role.

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. U.S. work‑authorization sponsorship (H‑1B, TN, J, etc.) is offered exclusively for Principal‑level roles and above. Roles below the Principal level require candidates to possess…