Senior Quality Engineer (Pharma)
Posted on Oct 30, 2021 by Experis AG
Senior Quality Engineer (Pharma)
For our client, Switzerland's leading medical device company, we are looking for a Senior Quality Source Engineer with experience in manufacturing/operations. This is initially a 12-month contract, with high extension possibility, based in Ticino, Switzerland. Italian language skills are required for this role.
Located in the Manufacturing Site in Ticino you will act as on-site as the quality engineering representative for the Strategic Collaborator (SC). In partnership with the SC, you will utilize quality engineering principles and problem-solving skills to improve and maintain our 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 to ensure that the SC has a clear understanding and ability to execute to the Quality Agreement requirements, Policies, and applicable regulations and standards.
- A minimum of a bachelor's degree, preferably in Engineering or related technical field.
- Around 4 to 6 years' experience 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 including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Ability to perform "hands on" troubleshooting and problem solving.
- Strong technical understanding of manufacturing equipment and processes.
- Business Fluent English and Italian
Nice to haves:
- Experience working in both an FDA and European regulatory environment
- Strong knowledge of statistical software packages with the ability to preview, graph and analyze 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.).
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 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 coordinates additional subject matter expert support needed from us.
- 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.
- Duration: 12 months
- Extension: possible
- Location: Ticino, Switzerland
- Workload: 100%
Interested in this opportunity? Kindly send us your CV today through the link in the advert. Should you have any questions please contact Nastasia Whyte.