Sr Quality Systems Engineer

Job description

We anticipate the application window for this opening will close on - 31 Jul 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 Life Our purpose: Acute Care & Monitoring solutions, we empower healthcare professionals with world-class technology to personalize patient care, anytime, anywhere. Our products can be found in various specialties: Respiratory Therapy, Critical care physicians and nurses, anesthesia, operating room, emergency medicine, first responders, hospital administration, operating room clinicians, and procedural sedation clinicians. In this exciting role as a Senior Quality Systems Engineer, it will be one of development, improvement, and innovation, through cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality systems engineering support in the development and maintenance of medical device products across the Acute Care and Monitoring (ACM) portfolio of products. You will facilitate the application of our Quality Management System in developing and sustaining our product portfolio. This position is in Lafayette, CO and requires on-site presence four days a week. A Day in the life of: Manage and drive the Corrective and Preventive Action (CAPA) Program.CAPA Specialist position is expected to be an expert in CAPA scoping, root cause analysis, action planning & execution, and techniques for verification of CAPA effectiveness. Able to mentor CAPA owners to ensure complete and defendable CAPAs including investigations, Root Cause Analysis and resulting Corrective and Preventive Actions, and developing sound effectiveness check plans. Effective communication of CAPA status to CAPA Board and escalation to applicable stakeholders. Responsible for CAPA process expertise, and assists CAPA Owners with compliance to CAPA requirements, guidance, and best practices. Provides oversight into the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides technical expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance. Supports internal and external audits and inspectionsManaging and driving audit and inspection finding investigations and resolutions with a cross-functional team. Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc. Key skills and Experience Requires a Level 8 degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience. Experience in the Medical Device Industry or a similar industry role CAPA ownership/execution experience, required Strong understanding of medical device regulatory and governmental regulations (EU MDR, FDA, MDSAP, ISO 13485, etc.) Experience in Risk Management ISO 14971 Medical Device Auditing Experience Project Management experience Strong analytical and problem-solving skills, excellent communication skills, excellent writing and editing skills, and computer skills in the English language. Ability to work effectively independently, within teams, and across functions. Ability to travel on occasion Needs to be updated for US Based Candidates 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):$98,400.00 - $147,600.00 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: Incentiv