Senior Quality Systems Specialist (MedTech)

Location: Nijmegen, Netherlands

Base pay: €64,000–€103,040 per year

Company

hirify.global develops healthcare and medical technology solutions, including ETHIZIA, a hemostatic sealing patch for surgical procedures.

What you will do

• Supervise the site Nonconformance/CAPA and escalation processes, and support Change Control and Training Management.
• Drive the implementation, continuous improvement, and compliance of quality management systems at the GATT facility.
• Use statistical methods, quality tools, and computer-generated reports to improve process capability and prepare data for management reviews.
• Coordinate quality planning, conduct internal audits, and support external audits with corrective action plans.
• Identify root causes of quality issues, develop corrective actions, and lead quality system improvement initiatives.
• Develop quality metrics, advise management, provide QMS training, and represent the site in worldwide process teams.

Requirements

• University or bachelor’s degree, or equivalent.
• 4–6 years of professional experience, including at least 3 years in a medical device or pharmaceutical environment.
• English communication and writing skills required.
• Strong communication, interpersonal, problem-solving, analytical, and documentation skills.
• Ability to work independently and in teams while maintaining accuracy, consistency, and quality.
• Understanding of regulated plant operations, quality system regulations, ISO standards, and FDA cGMPs.

Nice to have

• Dutch language skills.
• Experience with notified body or competent authority audits.
• Six Sigma, LEAN, or auditor certification.
• Experience developing or enhancing compliant quality system processes.

Culture & Benefits

• Inclusive work environment focused on respect, diversity, and individual contribution.
• Annual bonus based on pay grade, location, and employee and company performance.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Recognition awards and access to insurance plans subject to eligibility and plan terms.