Beschreibung
Job Title: Senior Quality Source Engineer (Supplier Quality Engineer)Located in the Manufacturing Site in Mezzovico (TI) the Site Senior Quality Source Engineer act as on-site at the client quality engineering representative for the Strategic Collaborator (SC).
Tasks & Responsibilities:
* Supports the Product Release Monitoring and Strategic Collaborator Employee Certification Program.
* Reviews and approves key quality records as they related to client products in accordance to the Quality Agreement, such as:
o Non-conformance 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 client products.
* Coordinates client review of non-conformance disposition in collaboration with other required client functions (such as Franchise Quality, Regulatory Affairs, etc.)
* Supports Strategic Collaborators Quality and Manufacturing Engineering on the resolution of quality issues impacting clients products and coordinates additional subject matter expert support needed from the client.
* Initiates Stop Shipments and Product Issue Escalations for products out of client control.
* 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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.