Position SummaryThe Quality Engineer at Datwyler is responsible for ensuring that products, processes, and quality systems comply with internal standards, customer requirements, and applicable regulatory requirements. This role supports manufacturing and new product introduction through risk management, process validation, continuous improvement, and root cause analysis, contributing to Datwyler's commitment to patient safety and product excellence.
Essential FunctionsQuality Systems & Compliance- Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and other applicable regulatory and customer requirements.
- Support internal, external, customer, and regulatory audits; prepare documentation and lead follow-up activities.
- Maintain and improve quality procedures, work instructions, and records.
Manufacturing & Process Support- Provide quality engineering support for manufacturing processes, including molding, assembly, inspection, and packaging.
- Oversight process validations (IQ, OQ, PQ) and maintain validation documentation.
- Participate in PFMEA, Control Plans, and risk management activities.
- Support containment, investigation, and resolution of nonconformities.
Continuous Improvement- Oversight and support root cause investigations using tools such as 8D, Fishbone, and 5-Why.
- Implement corrective and preventive actions (CAPA) and verify effectiveness.
- Drive continuous improvement initiatives using Lean and Six Sigma methodologies.
New Product Introduction (NPI)- Support quality planning and risk assessments for new products and transfers.
- Review customer specifications, drawings, and validation requirements.
- Ensure quality deliverables are completed on time for project milestones.
Supplier & Customer Quality- Support supplier qualification, audits, and performance monitoring.
- Investigate customer complaints and ensure timely, compliant responses.
- Collaborate with customers to resolve quality issues and improve satisfaction.
QualificationsEducation- Bachelor's degree in Engineering, Quality, Science, or a related discipline.
Experience- 2-5+ years of quality engineering experience in a regulated manufacturing environment, preferably medical device, pharmaceutical, or healthcare packaging.
- Experience with molding or precision manufacturing processes preferred.
Technical Skills- Strong knowledge of:
- ISO 13485
- FDA 21 CFR 820
- Risk management (ISO 14971)
- Process validation
- Experience with statistical tools and SPC.
- Proficiency in MS Office; experience with eQMS systems is a plus.
