GULP Information Services GmbH

Quality Engineer (m/f/d)

GULP Information Services GmbH

Frankfurt am Main
Ingenieurberufe, Techniker
Vollzeit

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

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