Manager of Quality Assurance (Medical Devices)

TL;DR

Manager of Quality Assurance (Medical Devices): Directing and managing QA operations in Class 3 PMA medical device manufacturing with an accent on compliance with FDA QMSR, ISO 13485, and ISO 14971. Focus on overseeing CAPA programs, internal/external audits, nonconforming material processes, trend analysis, and staffing for inspection and product release.

Location: Onsite in Pittsburgh, PA

Salary: $119,000 - $145,000

Company

hirify.global Medical Corporation provides innovative medical devices, software, and services for cardiopulmonary and respiratory conditions used worldwide.

What you will do

• Manage inspection and product release programs for incoming, in-process materials, and finished goods.
• Collect data and perform analysis on quality metrics.
• Liaise with external inspectors and auditors.
• Monitor QA processes to meet production schedules, audits, and calibrations.
• Lead Quality Engineering and Inspection departments with 20+ staff.
• Ensure compliance with all policies, standards, and business goals.

Requirements

• Bachelor's Degree required.
• Minimum 5 years management/leadership experience required.
• Minimum 4 years as QA engineer or technical role in medical device manufacturing (preferred).
• In-depth knowledge of 21 CFR 820, ISO 13485, and ISO 14971 required.
• Advanced problem-solving skills.
• Ability to develop strategies for organizational goals and best practices.

Nice to have

• ASQ Certified CQE, CRE, CQM.
• Lean Six Sigma.

Culture & Benefits

• Opportunity to impact lives through life-saving medical technologies.
• Comprehensive benefits plans including annual bonus eligibility.
• Work in a fast-growing company operating in 140+ countries.
• Culture emphasizing innovation, self-motivation, and entrepreneurial spirit.