Manager, Quality Engineering Product Surveillance (Bioprocessing)

Location: Marlborough, Massachusetts, United States

Base salary: $110,858–$156,358 per year, with eligibility for variable cash programs and, for eligible roles, equity.

Company

hirify.global develops bioprocessing technologies and solutions that support the production of biologic drugs and improve process and cost efficiency.

What you will do

• Lead complaint handling activities and maintain the electronic complaint management system.
• Direct complex investigations with Quality, Manufacturing, Engineering, and customer-facing teams to identify root causes and resolve product and service failures.
• Drive corrective and preventive actions, risk reduction, and continuous improvement initiatives.
• Communicate investigation findings and corrective-action updates to customers and internal stakeholders.
• Monitor complaint metrics and performance indicators to identify improvement opportunities.
• Develop, coach, and retain a high-performing Quality team while allocating resources to business priorities.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 7+ years of Quality Assurance and Quality Management Systems experience, including at least 3 years of leadership experience.
• Strong knowledge of ISO 9001 requirements and quality management system principles.
• Expertise in complaint handling, CAPA, root cause analysis, continuous improvement, electronic quality management systems, and internal and external quality audits.
• Ability to lead teams, influence cross-functional partners, manage stakeholders, and drive results with minimal supervision.
• Strong organizational, technical writing, communication, presentation, and software skills.

Nice to have

• Salesforce.com experience.

Culture & Benefits

• Leadership expectations emphasize integrity and compliance, customer focus, collaboration, courage, team empowerment, and accountability for results.
• Paid time off and health, dental, and vision benefits.
• Retirement benefits and flexible spending accounts.
• Variable cash programs and potential equity for eligible roles.