Senior Quality Systems Specialist (Medtech)

TL;DR

Senior Quality Systems Specialist (Medtech): Ensuring quality and compliance for process development and manufacturing of implantable cardiac and neuromodulation medical devices with an accent on regulatory adherence and systemic risk management. Focus on leading audit readiness, driving CAPA activities, and optimizing validation protocols (IQ/OQ/PQ).

Location: Tempe, Arizona, USA. Must be onsite 5 days a week

Salary: $93,600 - $140,400

Company

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

What you will do

• Provide oversight for the development and continuous improvement of quality programs, systems, and procedures to ensure regulatory compliance.
• Partner with engineering and operations to ensure quality standards are met during product realization and process development.
• Lead audit and inspection readiness, execution support, and resolution of findings.
• Design and implement inspection, testing, and evaluation methods to address nonconformance.
• Drive CAPA activities, including investigation support and effectiveness verification.
• Manage risk management (e.g., process FMEA) and change control implementation strategies.

Requirements

• Baccalaureate degree and minimum 4 years of relevant experience, or an advanced degree with 2 years of experience.
• Unrestricted U.S. work authorization required (Sponsorship not available for this level).
• Advanced knowledge of quality systems and regulatory standards.
• Experience in providing quality oversight for manufacturing and process development.

Nice to have

• Experience with electronics manufacturing, wafer fabs, or microelectronics assembly.
• Six Sigma or Lean Sigma belt certification.
• Experience with FDA, MDSAP, and/or TUV audits.
• Strong proficiency in statistical analysis techniques and DOE design.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan.
• Paid time off and holidays.