(Senior) Supplier Quality Engineer
Posted on Aug 25, 2021 by Experis AG
(Senior) Supplier Quality Engineer
Experis IT is Europe's leading IT recruitment agency. With operations in over 50 countries and offices in Zurich, Basel, Geneva and Lausanne, we will leverage our extensive client network to help you accelerate your career in Switzerland.
For one of our clients, a market leader in the medical device industry, we are looking for a Senior Supplier Quality Engineer. This is a challenging contracting role from 15th September 2021 until the 31st of December 2022 with possibility of extension.
Located in the Manufacturing site in Raron (VS) you will act as the quality engineering representative on-site for the Strategic Collaborator. In partnership with the Strategic Collaborator, you will 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. In addition, you will be responsible of ensuring that the Strategic Collaborator has a clear understanding and ability to execute to the Quality Agreement requirements, the companies Policies, as well as applicable regulations and standards.
Tasks & Responsibilities:
- Supporting the Product Release Monitoring and Strategic Collaborator Employee Certification Program
- Reviewing and approving key quality records as they related to our 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 our products
- Coordinating the review of nonconformance disposition in collaboration with other required functions (such as Franchise Quality, Regulatory Affairs, etc.)
- Supporting Strategic Collaborators Quality and Manufacturing Engineering on the resolution of quality issues impacting our products and coordinating additional subject matter expert support as needed
- Initiating Stop Shipments and Product Issue Escalations for products out of our control
- Supporting improvement plans to address below-target metrics and negative trends
- Partnering with SC on Recall Prevention and External Audit Readiness initiatives
- Serving as the Source Quality Manager deputy
- Bachelor's Degree, preferably in Engineering or a related technical field
- Background in manufacturing/operations
- Experience working in both an FDA and European regulatory environment
- 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.
- Ability to perform "hands on" troubleshooting and problem solving
- Good technical understanding of manufacturing equipment and processes
- Business Fluent English and German
Nice to Haves:
- 4 to 6 years related experience
- Strong knowledge of statistical software packages with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision-making.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise
- A thorough understanding of GMP/ISO regulations and validation regulations
- Quality Engineering Certifications (eg ASQ CQE, PMI PMP, 6-Sigma, etc.)
Is this position a match? Please apply through the button below, should you have any questions, don't hesitate to contact Ms. Nastasia Whyte.