Currently partnering with an international Medical Device Company, we are looking for a Senior Quality Source Engineer (Supplier Quality Engineer) for a 12 month contract in Ticino, starting January. As its in Ticino the candidate must speak italian.
Senior Quality Source Engineer (Supplier Quality Engineer)
Located in the Manufacturing Site in TICINO (CH the Site Senior Quality Source Engineer act as on-site quality engineering representative for the Strategic Collaborator (SC). In partnership with the SC, he/she utilizes quality engineering principles and problem-solving skills to improve and maintain products and processes, including validation, risk management, product quality issue resolution and critical issue, and quality systems performance monitoring. The Senior Quality Source Engineer is responsible for ensuring that the SC has a clear understanding and ability to execute to the Quality Agreement requirements, Company Policies, and applicable regulations and standards.
Tasks & Responsibilities:
* Supports the Product Release Monitoring and Strategic Collaborator Employee Certification Program.
* Reviews and approves key quality records as they related to the products in accordance to the Quality Agreement, such as:
o Nonconformance records (incl. CAPA's and Product Dispositions),
o Site Validation Master Plan and Validation protocols,
o Inspection plans and associated sampling strategies,
o Where necessary, collaborate in failure investigation and corrective action planning involving products.
* Coordinates review of nonconformance disposition in collaboration with other required functions (such as Franchise Quality, Regulatory Affairs, etc.)
* Supports Strategic Collaborators Quality and Manufacturing Engineering on the resolution of quality issues impacting products and coordinates additional subject matter expert support needed
* Supports improvement plans to address below-target metrics and negative trends.
* Partners with SC on Recall Prevention and External Audit Readiness initiatives.
* Serves as the Source Quality Manager deputy.
Qualifications & Experience
* A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. 4/ 6 years related experience preferred.
* Experience working in both an FDA and European regulatory environment is preferred.
* This position will require relevant background in manufacturing/operations.
* Experience with a consistent track record of implementing appropriate risk mitigation.
* Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-making.
* Ability to perform "hands on" troubleshooting and problem solving.
* Good technical understanding of manufacturing equipment and processes is required.
* Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
* 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
Please apply directly via the link.