Sr. Quality Systems Manager

Medtronic • North Haven, CT

1d

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career in IT that changes lives. Careers that Change Lives A Day in the Life POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:

Requirements

• MINIMUM REQUIREMENTS:
• EDUCATION REQUIRED: Bachelor’s Degree
• YEARS OF EXPERIENCE: Minimum of 7 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience
• Effective usage of data analysis tools, analytical and research skills, and problem-solving techniques with keen attention to detail and simultaneous understanding of the "big picture".
• Desire to follow an audit trail to identify risks, non-conformances, true root cause, etc.
• Outstanding written, oral communication, and presentation skills
• Sound judgement, ability to make decisions, work independently, and demonstrated leadership skills
• Ability to manage and execute on multiple critical projects simultaneously.
• Capable to manage multiple priorities and escalate issues.

Nice To Haves

• 3 or more years relevant experience in a Design & Development and/or Manufacturing setting

Responsibilities

• Provides oversight for 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 expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance.
• Responsible for communicating business-related issues or opportunities to next management level
• Lead, coordination and preparation of internal and external audits, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
• Own and drive Investigations, Root Cause Analysis and resultant Corrective Actions and Preventive Actions
• Perform trend analyses and report compliance observations to identify areas in need of improvement
• Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
• Demonstrated knowledge of applicable Quality, FDA (Food & Drug Administration) Medical Device Directives/ Regulation and ISO (International Organization for Standardization).
• Excellent writing and editing skills, and computer skills.
• Travel within US and International approximately 25%.

Benefits

• 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.
• 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: Mid Level
• Number of Employees: 5,001-10,000 employees