Sr. QA Engineer (Medtech)

TL;DR

Sr. QA Engineer (Medtech): Strengthening the facility Quality Management System (QMS) to meet regulatory and product quality requirements with an accent on QMS processes, audits, and risk assessments. Focus on implementing corrective and preventive controls (CAPA), executing regulatory audits, and ensuring compliance with ISO 13485 and GMP standards.

Location: Hybrid (Roosendaal, NL). Associates are expected to come to Roosendaal facility a minimum of 4 days per week.

Salary: 52,000 - 74,000 EUR annually

Company

Independent, employee-owned company developing and manufacturing healthcare products worldwide, specializing in ostomy, continence, and critical care.

What you will do

• Lead and support site-specific QMS processes, documentation controls, and work instructions.
• Prepare for and execute internal, external, and regulatory audits, ensuring evidence of compliance.
• Provide quality input on material disposition, process controls, and CAPA activities.
• Utilize structured problem-solving tools such as Fishbone, DMAIC, and 5-Whys for root cause analysis.
• Facilitate process FMEA, risk assessments, and validation planning.
• Coach and mentor colleagues on technical quality practices and audit readiness.

Requirements

• 5-8 years of overall experience, with 2-5 years specifically in a Quality role within the GMP Regulated Pharma/Medical Device industry.
• Bachelor’s degree in a relevant technical discipline such as quality, engineering, or life sciences.
• Proficiency in both English and Dutch (verbal and written).
• Proven experience supporting QMS processes, CAPA, change control, and risk assessment.
• Working knowledge of ISO 13485, GMP, and GDP frameworks.
• Strong technical writing skills for reports, procedures, and quality documentation.

Nice to have

• Experience in distribution quality or regulated distribution center operations.
• Certified auditor training or experience hosting regulatory audits.
• Expertise in Training Within Industry (TWI) methodology.
• Experience applying risk-based validation and project management practices.

Culture & Benefits

• Employee-owned company structure.
• Hybrid work environment with 4 days on-site.
• Opportunity to work for a global leader in healthcare selling in nearly 80 countries.
• Mission-driven culture focused on improving patient dignity and quality of life.