Quality Assurance Engineer
View: 92
Update day: 08-04-2024
Category: Consulting / Customer Service Arts / Design
Industry:
Job content
Reference Number: JO-2403-531307
Quality Assurance Engineer
Rate: Negotiable
Job Type: Permanent
Location: Geneva
Our client is looking for a talented Quality Assurance Engineer to join their team in Geneva. The Quality Assurance Engineer will play a key role in ensuring the quality and safety of our medical devices throughout the manufacturing process, from design and development to production and distribution.
Responsibilities:
– Develop, implement, and maintain quality assurance processes and procedures in compliance with regulatory requirements and industry standards (e.g., ISO 13485, FDA QSR).
– Review and approve design and process changes to ensure they meet quality and regulatory requirements.
– Perform risk assessments and analysis of product and process changes to identify potential quality issues and develop mitigation strategies.
– Conduct internal audits and assessments to evaluate compliance with quality management systems and identify areas for improvement.
– Collaborate with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain to address quality issues and drive continuous improvement.
– Investigate and resolve product quality issues, non-conformities, and customer complaints, implementing corrective and preventive actions as necessary.
– Support supplier quality management activities, including supplier qualification, audits, and performance monitoring.
– Participate in regulatory inspections and external audits, providing documentation and support as needed.
Requirements:
- Bachelor’s degree in engineering, quality assurance, or a related field; advanced degree preferred.
– 3+ years of experience in quality assurance or regulatory affairs in the medical device industry.
– Strong knowledge of quality management systems, regulations, and standards applicable to medical devices (e.g., ISO 13485, FDA QSR, MDD/MDR).
– Experience with risk management methodologies (e.g., ISO 14971) and quality tools such as FMEA, CAPA, and statistical analysis.
– Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions.
– Effective communication and collaboration skills, with the ability to work cross-functionally and influence stakeholders at all levels.
– Fluency in English and French
Deadline: 23-05-2024
Click to apply for free candidate
Report job
SIMILAR JOBS
-
⏰ 27-05-2024🌏 Baar, Zug ZG
-
⏰ 27-05-2024🌏 Gland, Vaud VD
-
⏰ 27-05-2024🌏 Neuchâtel, Neuchâtel NE
-
⏰ 27-05-2024🌏 Arbon, Thurgau TG
-
⏰ 27-05-2024🌏 Aarau, Aargau AG
-
⏰ 27-05-2024🌏 Zürich, Zürich ZH
-
⏰ 27-05-2024🌏 Zürich, Zürich ZH
-
⏰ 27-05-2024🌏 Zürich, Zürich ZH
-
⏰ 27-05-2024🌏 Genève, Genève GE
-
⏰ 27-05-2024🌏 Einsiedeln, Schwyz SZ