Sr Quality Systems Engineer

Medtronic • Lafayette, CO

1d • $98,400 - $147,600 • Hybrid

About The Position

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.

Requirements

• 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.

Responsibilities

• 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 inspections
• Managing 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.

Benefits

• 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
• Simple Steps (global well-being program)
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior