Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Independently plan and oversee Risk Management Activities for medical devices including ARisk Analysis DDMEA and PFMEA in compliance with ISO 14971.
- Collaborate with risk management staff to conduct Risk/FMEA assessments.
- Serve as the primary contact for customers on qualityrelated matters ensuring efficient coordination and communication.
- Define and implement Validation Strategies based on regulatory and customer requirements following a riskbased 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.
- Indepth knowledge of relevant standards such as ISO 13485 ISOCFR 820 and ISO 14971.
- Strong understanding of statistical and quality management methods at a professional level.
- Excellent analytical skills with practical experience in systematic problemsolving techniques such as KT Six Sigma and FaultTree Analysis.
Additional Information :
Your contact person: Gabrielle Holland
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
