Quality Engineer (m/f/d)

Sounds good? We look forward to receiving your online application. Equal opportunities are very important to us - applicants with a disability are very welcome!

• Accountable for DHF oversight and maintenance for the post-launch stage in collaboration with the global device unit design center
• Ensure DHF maintenance procedures and relevant processes are robust, standardized, and adequately maintained following regulatory requirements and best practices
• Create and maintain all DHFs structure according to defined process and system in coordination with project teams accountable for new product development or design change projects
• Support audits or inspections requiring access to DHFs
• Perform DHF reviews/audits as required to support Design Reviews, audit preparations or part of continuous improvement activities related to DHF maintenance process
• Lead DHF remediation efforts
• Lead continuous improvement projects or activities which may include product or process improvements and remediation efforts (ie DHF, Risk Management Files, etc.)
• Contributing to network forums to support for aligned process execution in the different networks
• Coordinating the Device & Packaging Change Board for GDPU and change control communication within the network
• Supporting the assessment for network impact and design consistency (e.g. DHF/DMR, Alliance impact etc.) for inter-site change controls between GDPU and network sites
• Act as the Single Point of Contact (SPOC) for manufacturing sites of medical devices or combination products for device related Change Controls topics and operational knowledge transfer
• Provide mentoring support to Quality Engineers, as instructed by the Manager
• Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results
• MS degree in Engineering or related science discipline
• An advanced degree is a plus
• Relevant experience (5 years+) in the medical device industry
• Knowledge of Six Sigma Tools or Six Sigma Green Belt certification is highly preferred
• Excellent knowledge of relevant regulatory requirements related to medical devices, drug-device-combination products as per e.g. 21 CFR 820, ISO 13485, EU Medical Device Regulation, ISO 14971, ISO 10993
• Certified Quality Engineering – ASQ certification preferred (CQE)
• Good communication and presentation skills toward colleagues and international external partners
• Good knowledge of project management and problem-solving/troubleshooting methodologies (GPS) are an advantage
• Business fluent in English (written and oral), any other language as a plus
• Direct recruitment into a permanent position at our customer
• Salary structure depending on qualifications and professional experience
• Possibility for mobile working on 3 days of the week
• Numerous direct contacts with personnel decision-makers
• Appreciative and trustworthy support during the entire placement process