Manager, Quality Systems (Medical Devices)

Location: Warrendale, Pennsylvania, United States; onsite

Salary: $115,000–$130,000 yearly plus a 10% annual target bonus.

Company

hirify.global operates a medical device production unit within its Devices Division.

What you will do

• Develop and deliver quality compliance strategies aligned with global, divisional, local, and international regulations.
• Execute and improve quality system activities, including CAPA, management controls, complaint investigations, internal auditing, change control, and document control.
• Monitor quality system performance and report on compliance health, inspection readiness, and audit results.
• Develop and lead a cross-functional internal audit program.
• Represent the local quality system during regulatory inspections and manage external audits and post-audit activities.
• Lead QMS initiatives, resolve compliance issues, and coach quality management teams.

Requirements

• Bachelor’s degree in life science, engineering, physical science, or a related discipline.
• 8–10 years of experience with medical device regulatory requirements for globally distributed products.
• In-depth knowledge of 21 CFR Parts 11 and 820, ISO 13485, ISO 14971, QSR, MDD, CMDR, MDSAP, and MEDDEV requirements.
• Experience working directly with FDA inspectors and other regulators during quality system audits.
• Must be currently authorized to work in the United States for any employer and maintain that authorization without employer sponsorship.
• Effective spoken and written English is required.

Nice to have

• Lead Auditor or ASQ professional certification, such as ISO 9001/13485 Lead Auditor or ASQ CQA.
• Front Room Audit experience.
• Experience with Microsoft Office, PC SAS, or other analytical software.

Culture & Benefits

• Medical, dental, and vision coverage.
• Life insurance and disability coverage.
• 401(k) with company contribution.
• Wellness program.
• At-will employment arrangement.