Quality Systems Specialist (Medtech)

TL;DR

Quality Systems Specialist (Medtech/QMS): Supporting the development, implementation, and maintenance of quality programs and systems to ensure compliance with FDA and ISO standards with an accent on audit readiness and QMS processes. Focus on managing the Operations Quality Walk program, coordinating regulatory inspections, and administering SAP QM data.

Location: Santa Ana, California, USA. Working onsite 4 days a week.

Salary: $75,200 - $112,800

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Develop and maintain quality programs and procedures to ensure regulatory compliance.
• Coordinate internal and external audits, including FDA and Notified Body inspections.
• Manage the Operations Quality Walk (OQW) program to identify and track compliance gaps.
• Administer SAP QM Local Data Administrator (LDA) activities and system configurations.
• Utilize root cause analysis and continuous improvement tools to address quality issues.
• Support Quality Management Reviews (QMR) by preparing reports and metrics.

Requirements

• Bachelor’s degree with minimum 2 years of relevant experience.
• Unrestricted U.S. work authorization is required.
• Ability to work onsite in Santa Ana, CA 4 days per week.

Nice to have

• Experience with FDA 21 CFR Part 820 and ISO 13485.
• Knowledge of CAPA, nonconformance, and change control processes.
• Familiarity with Lean, Six Sigma, or MDSAP.
• Experience with TrackWise, Agile, Windchill, or SAP QM.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA/FSA options.
• 401(k) plan with employer contribution and match.
• Employee Stock Purchase Plan and short-term incentive plans (MIP).
• Tuition reimbursement and global well-being program (Simple Steps).
• Paid time off and paid holidays.