Sr. Manager of Quality Assurance (Medical Devices)

TL;DR

Sr. Manager of Quality Assurance (Medical Devices): Leading quality assurance operations and maintaining the Quality Management System for Class 3 PMA medical devices with an accent on product release, regulatory compliance, quality engineering, and process improvement. Focus on managing complex quality issues, driving CAPA and risk-management strategies, analyzing quality data, and ensuring compliance with FDA, ISO 13485, ISO 14971, MDR, and ATF requirements.

Location: Onsite in Pittsburgh, Pennsylvania, United States.

Salary: $140,000–$180,000 per year.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions.

What you will do

• Manage inspection and product release programs for incoming materials, in-process materials, and finished goods.
• Lead the Quality Engineering and Inspection Departments and oversee day-to-day QA operations.
• Monitor quality processes, schedules, audits, calibrations, and performance metrics.
• Act as an escalation point for complex quality issues and coordinate cross-functional resolution.
• Create and maintain inspection instructions, perform trend analysis, and present quality reports to management.
• Lead or support company-wide CAPA, risk management, change control, and PLM strategies.

Requirements

• Bachelor’s degree required; a master’s degree in engineering or an MBA is preferred.
• At least 7 years of management or leadership experience.
• At least 4 years of quality assurance engineering or technical experience in medical device manufacturing preferred.
• In-depth knowledge of 21 CFR 820, ISO 13485, ISO 14971, and European MDR requirements.
• Experience leading teams, managing complex projects, analyzing data, and applying Lean and Six Sigma methods.
• Strong communication, organizational, problem-solving, and cross-functional coordination skills.

Nice to have

• ASQ CQE, CRE, or CQM certification.
• Lean Six Sigma certification or advanced experience.
• Master’s degree in engineering or an MBA.

Culture & Benefits

• Work at a fast-growing medical technology company operating in more than 140 countries.
• Contribute to technologies designed to improve outcomes for patients with critical cardiopulmonary conditions.
• Culture focused on innovation, self-motivation, entrepreneurship, and continuous improvement.
• Comprehensive employee benefits are available.