Quality Systems Specialist

Medtronic•Minneapolis, MN

23h•$75,200 - $112,800

About The Position

The Quality Systems Specialist provides quality-system support and oversight for Medtronic’s EU Surgical Operating Unit entities. The role supports proactive quality-system activities, including helping entities establish QMS processes and supporting audits and certifications, as well as reactive support for production-quality issue resolution, PHO, and FCA activities. The specialist helps maintain compliance with FDA and international regulatory requirements and works with internal and external stakeholders to implement compliance-related changes. The position leads investigations, root-cause analysis, and corrective and preventive actions; supports the development and maintenance of quality systems, programs, processes, and procedures; coordinates or prepares internal and external audits; and analyzes trends to identify compliance improvements. It also investigates compliance issues raised by company units, customers, and regulatory agencies, and communicates business issues or opportunities to management. The role requires travel within the United States and internationally, approximately 25%.

Requirements

Bachelor’s degree.
At least 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
Demonstrated knowledge of quality-system elements and regulatory requirements for finished medical devices, including FDA, GMP, QSR, ISO 13485, and MDSAP.
Ability to implement and communicate regulatory and quality-system requirements in a government-regulated healthcare industry, with a focus on Core QMS, Design Control, and manufacturing processes and requirements.
Effective use of data-analysis tools, analytical and research skills, and problem-solving techniques, with attention to detail and an ability to understand the broader context.
Ability and willingness to follow an audit trail to identify risks, non-conformances, and root causes.
Outstanding written, oral communication, and presentation skills.
Sound judgment, decision-making ability, ability to work independently, and demonstrated leadership skills.
Ability to manage and execute multiple critical projects simultaneously, manage competing priorities, and escalate issues.
For a baccalaureate degree earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice To Haves

At least 1 year of relevant experience in a Design & Development and/or Manufacturing setting.
Experience supporting and/or participating in regulatory inspections and audits.

Responsibilities

Own and drive investigations, root-cause analysis, and resulting corrective and preventive actions.
Provide quality-system support and guidance to maintain compliance with FDA and international regulatory requirements.
Oversee development and maintenance of quality systems, programs, processes, and procedures to ensure compliance with Medtronic policies and global regulatory requirements.
Provide proactive and reactive quality oversight support to EU Surgical Operating Unit entities, including QMS setup, audits and certifications, production-quality issue resolution, and PHO and FCA support.
Partner with and influence internal and external stakeholders to drive necessary changes and compliance-program execution.
Communicate business-related issues or opportunities to the next management level.
Lead, coordinate, and/or prepare internal and external audits in accordance with regulatory standards for the Operating Unit.
Perform trend analyses and report compliance observations to identify areas for improvement.
Investigate and resolve compliance problems, questions, or complaints received from company units, customers, and government regulatory agencies.
Maintain knowledge of applicable quality, FDA medical-device, HIPPA, and ISO requirements by updating policies and procedures and acting as a liaison with policy experts.
Travel within the United States and internationally, approximately 25%.
Use strong writing, editing, and computer skills in carrying out the role.

Benefits

Competitive salary and flexible benefits package.
Short-term incentive eligibility through the Medtronic Incentive Plan (MIP).
Health insurance.
Dental insurance.
Vision insurance.
Health Savings Account.
Healthcare Flexible Spending Account.
Life insurance.
Long-term disability leave.
Dependent daycare spending account.
Tuition assistance/reimbursement.
Global well-being program (Simple Steps).
Incentive plans.
401(k) plan with 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.