Senior Manager, Quality Assurance (Medical Devices)

Location: Site-based in Clinton, Pennsylvania, United States

Salary: $124,300–$211,700 annually, plus potential discretionary annual bonus and long-term incentive plan eligibility.

Company

hirify.global develops products and solutions for the medical technology industry.

What you will do

• Lead implementation, maintenance, and continuous improvement of the site Quality Management System.
• Oversee compliance activities, internal audits, management reviews, quality meetings, KPI monitoring, and trend analysis.
• Partner with plant management and cross-functional teams on design and engineering changes, quality planning, verification, and validation.
• Initiate and monitor CAPAs and proactively resolve quality issues across manufacturing operations.
• Represent the site in customer, contractor, FDA, and ISO quality system audits and inspections.
• Oversee inspection, sampling, and testing programs and mentor Quality team members.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• 8+ years of progressive Quality Assurance or Quality Systems experience in a regulated industry.
• 5+ years of leadership experience managing quality teams.
• Experience with FDA regulations, ISO 13485, MDSAP, and global regulatory requirements.
• Experience in medical devices, biotechnology, pharmaceuticals, or combination products, including manufacturing support and quality system compliance.
• Experience leading CAPA, Complaints, Design Assurance, Audits, Validation, and Supplier Quality functions.

Nice to have

• Advanced degree such as an MS or MBA.
• Experience with MDR and/or IVDR regulations.
• Six Sigma Green Belt, Black Belt, ASQ certification, or equivalent quality certification.

Culture & Benefits

• Full-time employment in a diverse and dynamic work environment.
• 401(k) with up to a 6% employer match and no vesting period.
• Employee stock purchase plan and flexible time off for salaried employees.
• Paid sick time, paid and floating holidays, parental leave, and short- and long-term disability insurance.
• Tuition reimbursement and health and welfare benefits.