We have an opening for a quality, validation engineer to join a project to oversee a compliance of validation and verification activities for a medical devices manufacturing site.
Skills required: • Strong engineering skills with working knowledge of: Process validation/verification activities, projects with major scope (Titanium Anodization, Electropolishing, Passivation, Sterilit/ final clean and packaging, testing of orthopedic implants
• Experience in Change Control, Manufacturing/Product Transfers, Outsourcing Initiatives
• Knowledge of the QSR, Design Controls, and ISO 13485 quality requirements. A minimum of 5 years of related experience is required, preferably within a regulated environment (e.g. FDA, ISO 13485regulated).
• Experience conducting Process / Design Failure Mode Effects and Analysis.
• Knowledge on Statistical techniques and methods, capability studies.
• Experience in Control Plans, inspection methods and techniques, First Article Inspection, Test Method Validation/ GR&R.
• Experience with Blueprint reading/literacy including Geometric Dimensioning and Tolerance (GD&T).
• Ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required. Problem solving techniques including 8D, root cause analysis and cause and effect analysis. Experience in CAPA execution and management.
• Quality Engineering/Design or Process Excellence/Lean experience is preferred. ASQ certifications are an asset.
• Engineering, Technical, or Scientific discipline is required. An advanced degree in a related field is an asset.
• Experience with project management.
• Ability to work independently and partner with a cross-functional team (supplier, R&D, Regulatory, Manufacturing, and Purchasing etc).
• Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
• Excellent written and oral communication skills.
• Ability to provide regular updates to project leader and team at various forums
• Organizational talent, reliability, dependability, personal initiative, customer / service orientation.
This is a 6 months contract position till middle of October in German part of Switzerland.
Please call Beata Klecz on 0041 442152052
Michael Bailey International is acting as an Employment Business in relation to this vacancy.