Quality Systems Specialist

Medtronic • North Haven, CT

6d

About The Position

Medtronic is hiring a Quality Systems Specialist to provide quality-system oversight and support for EU Surgical Operating Unit entities. The role supports ongoing compliance with FDA and international regulatory requirements, including proactive assistance with quality management system processes, audits, and certifications, as well as reactive support for production-quality issues, PHO, and FCA. The specialist partners with internal and external stakeholders to drive compliance and needed change, communicates business issues and opportunities to management, and supports continuous improvement through investigations, audits, and trend analysis. The position involves approximately 25% travel within the United States and internationally.

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, and the ability to implement and communicate those requirements in a regulated healthcare industry.
• Knowledge focused 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 understanding of the broader context.
• Ability and desire to follow an audit trail to identify risks, nonconformances, and root causes.
• Strong written, oral communication, and presentation skills.
• Sound judgment, decision-making ability, independence, and demonstrated leadership skills.
• Ability to manage and execute multiple critical projects simultaneously, manage priorities, and escalate issues.
• For bachelor’s degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• At least 1 year of relevant experience in a design and 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 the development and maintenance of quality systems, programs, processes, and procedures to ensure compliance with Medtronic policies and global regulatory requirements.
• Provide proactive quality oversight to EU Surgical Operating Unit entities, including support with QMS processes, audits, and certifications, and reactive support for production-quality issue resolution, PHO, and FCA.
• Partner with and influence internal and external stakeholders to drive needed change and execute compliance programs.
• 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, including FDA and equivalent authorities outside the United States.
• Perform trend analyses and report compliance observations to identify improvement opportunities.
• Investigate and resolve compliance problems, questions, or complaints 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 approximately 25% within the United States and internationally.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive 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.

What This Job Offers

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