Quality Supplier Engineer medical devices

Beschreibung

Quality Supplier Engineer medical devices - 12 months contract - Switzerland
Tasks & Responsibilities:
* Supports the Product Release Monitoring and Strategic Collaborator Employee Certification Program.
* Reviews and approves key quality records as they related to 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 from
* 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.
* 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.