Quality Engineer II

Job description

We anticipate the application window for this opening will close on - 25 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the LifeThe Mystic site is part of the Ear, Nose and Throat business and manufactures Merocel® sponge Class I medical devices used to support patient care. The Quality function partners with manufacturing, engineering, and operations teams to maintain compliance, support product quality, and drive continuous improvement across quality system processes. This position is based in Mystic, Connecticut and requires onsite support five days per week to effectively partner with cross-functional teams and support manufacturing operations. No travel is required for this role. As a Quality Engineer II, you will support quality system activities within a regulated medical device manufacturing environment, with a focus on nonconformance management, corrective and preventive action (CAPA), calibration, process and equipment validation, and compliance with applicable regulatory requirements. This role collaborates across functions to maintain quality system effectiveness, support manufacturing operations, and drive continuous improvement initiatives. Primary Responsibilities Support nonconformance investigations and partner with cross-functional teams to identify root causes and implement corrective actions. Facilitate Corrective and Preventive Action (CAPA) activities, including documentation, effectiveness verification, and closure. Maintain compliance of calibration programs and support calibration-related quality activities. Execute and support process and equipment validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and related validation documentation. Collaborate with manufacturing and engineering teams to establish, implement, and maintain product and process quality requirements. Develop, revise, and maintain quality documentation, procedures, and records to ensure compliance with quality system requirements. Analyze quality data and trends to identify improvement opportunities and support risk-based decision-making. Participate in internal audits, inspections, and regulatory readiness activities to ensure ongoing compliance. Required Qualifications Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience. Experience supporting quality system processes within a regulated manufacturing environment. Experience with nonconformance investigations, root cause analysis, and corrective action implementation. Working knowledge of quality documentation requirements and regulatory compliance standards. Ability to manage multiple projects and priorities while maintaining accurate and compliant documentation. Preferred Qualifications Experience within the medical device industry. Working knowledge of TrackWise quality management systems. Experience using SAP to support quality, manufacturing, or calibration activities. Knowledge of calibration management and process or equipment validation activities. Strong analytical skills with experience evaluating quality data and driving process improvements. 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to 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 that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. ‌ Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$79,200.00 - $118,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to