Senior Manager Quality Assurance (Medical Device)

Location: East Greenbush, New York, United States. Work is performed onsite Monday–Friday, 8:00 a.m.–4:30 p.m.

Salary: $126,300–$206,100 annually

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.

What you will do

• Lead and develop quality engineering and compliance teams.
• Standardize and improve processes across sustaining engineering and compliance.
• Implement digital, data-driven tools for accurate and timely reporting.
• Provide quality assurance oversight for combination product sustaining engineering, including risk assessments, design changes, design reviews, and maintenance of design history and risk management files.
• Act as Management Representative for the combination products quality management system and own related policies and procedures.
• Support regulatory inspections, partner audits, project milestones, and post-commercialization activities.

Requirements

• Bachelor’s degree in Engineering and 8+ years of experience, including combination product or medical device experience, or an equivalent combination of education and experience.
• Previous supervisory or people leadership experience.
• Knowledge of combination device development and lifecycle processes.
• Ability to work onsite in East Greenbush, New York, Monday–Friday during scheduled business hours.

Culture & Benefits

• Inclusive workplace and equal employment opportunity commitment.
• Comprehensive total rewards package may include annual bonuses, incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during the recruitment process where required.