Quality Engineer / Design Control
Our client is a medical technology company dedicated to advancing the treatment of ear, nose, and throat (ENT) conditions through evidence-based innovation. We provide treatments for people with chronic sinusitis, an inflammatory sinus condition that has been shown to substantially reduce quality of life. Our clients core technology is an absorbable, steroid eluting implant which is a fascinating Class lll medical device which drastically improves patients’ quality of life.
PURPOSE OF JOB:
Responsible for supporting new product development deliverables related to Quality and the successful completion of individual projects. Must establish and maintain quality assurance standards that adhere to the Quality System Regulations (QSR) and International Standards Organization (ISO) regulations. Contribute to the development of our devices by managing requirements and translating them into meaningful implementation.
Support the development team by leading quality product-development deliverables (e.g. Risk management plan, Risk Analysis, Verification plan/report Validation Plan/report, traceability charts)
Support the design team by supporting non-quality product-development deliverables (e.g., Design Description Document, Product Specification)
Record, check and evaluate functional requirements that you receive from our interdisciplinary development team and manage their implementation for new products as well as for ongoing projects.
Perform Preliminary Hazard analyses (PHA) and design and process and/or Failure Modes and Effects Analyses (FMEA) throughout all design phases of the project
Statistical data analysis and interpretation to support investigations and specification setting activities
Determine sampling plans and create test protocols based on statistical rationale
Evaluate test methods and support test method development activities (protocol and report generation for gage Reproducibility and Repeatability (R&R) testing)
Identify and assist with implementation of preventive and corrective actions via Corrective and Preventive Action (CAPA) procedures, audits, Non-Conformities in context of the design activities.
Ensure that all documents reviewed/ approved follow written procedures and process specifications.
Ensure and maintain good documentation practice throughout the design process.
May develop and update documentation (Work Instructions, Standard Operating Procedures) that support the Quality Management System (QMS)
Participate in inspections for Federal Drug Administration (FDA), Food and Drug Branch (FDB), ISO, Medical Device Regulation (MDR), and other regulatory agencies
Periodically support internal audits and support external audits of key suppliers (as Subject Matter Expert)
Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
What you bring:
Required: Bachelor's degree in Engineering, Computer Science, or similar.
Minimum of 3 years’ Quality Engineering experience in medical device or related industry.
2 years’ experience of quality system elements and current Good Manufacturing Practices (GMP).
Experience in the areas of requirements definition or verification management in development projects in a regulated environment
Experience in design control or requirement management is required; Familiarity with ISO 14971.
28 days holiday
Friendly and Supportive culture (A good culture is a core focus for our client)
Full-time Permanent Position
Great Location just outside of Berlin
Flexible Working Hours
For more information or to apply please email email@example.com