Supplier Quality Engineer

Silke-Kathrin Kroh is recruiting for a Supplier Quality Engineer to join a leading medical device company at their manufacturing facility based at their site in Mezzovico. This position is offered on a contract basis for 12 months.

Supplier Quality Engineer Role:

• Utilizes quality engineering principles and problem-solving skills to improve and maintain company products and processes
• Validation, risk management, product quality issue resolution and critical issue, and quality systems performance monitoring
• Reviews and approves key quality records as they related to company products in accordance to the Quality Agreement
• Nonconformance records (incl. CAPA’s and Product Dispositions)

Key duties will include:

• Site Validation Master Plan and Validation protocols
• Inspection plans and associated sampling strategies
• Partners with team members on Recall Prevention and External Audit Readiness initiatives

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

• A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Previous related experience preferred
• Experience working in both an FDA and European regulatory environment is preferred
• Background in manufacturing/operations particularly within medical devices
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC,DOEs, Reliability, etc.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Quality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).
• Business Fluent English and Italian required

This is an excellent opportunity to join a global medical device company.

For more information or to apply for this position, please contact Silke-Kathrin Kroh on 0041 (0) 800 106 106 or email Skroh@ckqls.ch. Please quote reference 52051 inall correspondence.