If you are thinking about a new career start, then we should talk! A business partner of Randstad professional solutions from the pharmaceutical industry currently has an exciting position as Senior Quality Engineer in Frankfurt. A variety of tasks, a working atmosphere characterised by appreciation and attractive benefits await you - all in a permanent position directly with the client. 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