Senior Quality Systems Specialist (MedTech)

TL;DR

Senior Quality Systems Specialist (MedTech): Leading and supporting Corrective and Preventive Action (CAPA) activities to ensure compliance with regulatory requirements and quality standards with an accent on root cause investigation and training system effectiveness. Focus on implementing effective corrective actions, managing quality audits, and maintaining QMS documentation.

Location: Onsite in Memphis, Tennessee, USA. Must possess unrestricted U.S. work authorization at the time of hire.

Salary: $89,600 - $134,400

Company

Global healthcare technology leader focused on alleviating pain, restoring health, and extending life through engineering and innovation.

What you will do

• Lead CAPA activities to investigate quality issues, identify root causes, and implement effective corrective and preventive actions.
• Provide oversight for the development and maintenance of quality programs, systems, and procedures to ensure regulatory compliance.
• Lead audit and inspection preparation and manage the resolution of audit findings.
• Improve training programs and ensure training matrices are accurately assigned to all job profiles.
• Develop and maintain work instructions and quality documentation.
• Collaborate cross-functionally with Manufacturing, Quality, and Engineering stakeholders.

Requirements

• Bachelor’s degree and minimum of 4 years of work experience in quality or a regulated industry.
• Alternatively, an advanced degree with a minimum of 2 years of experience in quality or a regulated industry.
• Unrestricted U.S. work authorization is required (sponsorship is not available for this role).

Nice to have

• Experience supporting CAPA processes and QMS activities using Agile MAP and TrackWise systems.
• Ability to develop and maintain work instructions while ensuring process compliance.
• Experience coordinating audit backrooms and facilitating auditor interactions.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and FSA options.
• 401(k) plan with employer contribution and matching.
• Paid time off, paid holidays, and a global well-being program.
• Tuition assistance and reimbursement for professional development.
• Employee Stock Purchase Plan and short-term incentive plans (MIP).