Quality Engineer

Job Description

• Independently plan and oversee Risk Management Activities for medical devices, including A-Risk Analysis, D-DMEA, and P-FMEA, in compliance with ISO 14971.
• Collaborate with risk management staff to conduct Risk/FMEA assessments.
• Serve as the primary contact for customers on quality-related matters, ensuring efficient coordination and communication.
• Define and implement Validation Strategies based on regulatory and customer requirements, following a risk-based approach, and document them in VMP and CRS/PRS.
• Oversee validation activities, ensuring alignment with the Validation Master Plan, product specifications (CRS), and qualification/validation plans.
• Establish and execute criteria for visual inspections of parts and assemblies during qualification and validation activities.
• Plan and manage Product Design Verification Activities independently.
• Define quality requirements for purchased parts and coordinate with suppliers to ensure compliance with these standards.

Qualifications

Qualifications: 

• Technical education or equivalent qualification, such as a degree in mechanical engineering or training as a mechanical/injection molding technician, with at least 5 years of professional experience in the medical or pharmaceutical industry.
• Extensive experience in the field of Quality Engineering or Quality Management.
• Proficient in office software including SAP, MS Excel, MS Word, and MS PowerPoint at an advanced level.
• In-depth knowledge of relevant standards, such as ISO 13485, ISO 15378, 21 CFR 820, and ISO 14971.
• Strong understanding of statistical and quality management methods at a professional level.
• Excellent analytical skills, with practical experience in systematic problem-solving techniques such as KT, Six Sigma, and Fault-Tree Analysis.

Additional Information

Your contact person: Gabrielle Holland ([email protected])

All your information will be kept confidential according to EEO guidelines.