Senior Quality Assurance Engineer

About the role

We are looking for a Senior Quality Assurance Engineer to ensure our products meet all regulatory and quality standards. You will work closely with operations and support internal and external audits while driving continuous improvement.

Key responsibilities

• Maintain compliance with all regulatory requirements of the Quality System.
• Support internal and external audits.
• Plan, coordinate, execute, and document validation studies, risk analyses (e.g., FMEA), process capability studies, and process improvements.
• Investigate customer complaints and CAPAs, perform root‑cause analysis, and implement corrective solutions.
• Partner with operations to achieve Global Quality Management objectives aligned with Hollister’s mission and vision.

Required profile

• 2–5 years of experience in quality engineering within medical device, pharmaceutical, biotech, food, or related industries.
• Degree in Engineering, Mathematics, Natural Sciences, Computer Science, or a related technical field.
• Very good English language skills.
• Experience working in self‑directed teams is preferred.

Required skills

• Validation studies
• FMEA (Failure Mode and Effects Analysis)
• Process capability analysis
• Process improvement methodologies
• CAPA investigation and resolution
• Regulatory compliance and audit support
• Injection molding techniques (preferred)
• Film sealing techniques (preferred)

What we offer

• Learning‑and‑development oriented culture
• Annual performance‑based bonus
• Comprehensive benefits package including health insurance
• Flexible working hours
• Fresh and healthy breakfast and lunch at the site restaurant at an exclusive price
• Team‑building events, summer festivals, and special activities
• Free charging stations for electric cars
• 24/7 accident insurance