Senior Quality Engineer

Job content

Supplier Quality Engineer

Location: Mezzovico (TI)

Duration: 1 year

Tasks

• Act as on-site Medical Devices quality engineering representative for the Strategic Collaborator
• Utilize 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
• Responsible for ensuring that the Strategic Collaborator has a clear understanding and ability to execute to the Quality Agreement requirements, policies, and applicable regulations and standards.
• Support the Product Release Monitoring and Strategic Collaborator Employee Certification Program.
• Review and approve key quality records as they relate to products in accordance to the Quality Agreement, such as:
• Nonconformance records (incl. CAPA’s and Product Dispositions),
• Site Validation Master Plan and Validation protocols,
• Inspection plans and associated sampling strategies,
• Where necessary, collaborate in failure investigation and corrective action planning involving products.
• Coordinate review of nonconformance disposition in collaboration with other required functions (such as Franchise Quality, Regulatory Affairs, etc.)
• Support Strategic Collaborators Quality and Manufacturing Engineering on the resolution of quality issues impacting products and coordinates additional subject matter expert support needed.
• Initiate Stop Shipments and Product Issue Escalations for products out of control.
• Support improvement plans to address below-target metrics and negative trends.
• Partner with the Strategic Collaborator on Recall Prevention and External Audit Readiness initiatives.
• Serve as the Source Quality Manager deputy.
  

Requirements

• 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
  

Keywords:Pharmaceuticals,Supplier Quality Engineer, Medical Devices, Engineering, manufacturing, operations, Statistics, Lean and Six Sigma, GMP, ISO, Switzerland, Lugano

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.