Quality Engineer, Principal Design Assurance Specialist
Quality Engineer, Principla Design Assurance Specialist
Direct Hire with full benefits
The Selected candidate will apply your medical device designassurance expertise to ensure our medical devices are safe, effective, anddelivered to our customers on time.
As a member ofthe QA/RA team you will provide design assurance support to product development;ensuring that the Quality Management System is being followed so that alldesign and development activity is fully compliant with global medical deviceregulations and standards.
You will be a keyparticipant on the engineering and manufacturing teams to ensure that theappropriate documentation (DHF, Design Dossier, Technical File, etc.) isgenerated.
· Work closely with new product developmentteams and other appropriate departments to develop quality plans, contribute todesign reviews and risk management as well as provide guidance to ensure thatdesign and other documentation is consistent and compliant to regulations, andis appropriate for the DHF and Technical files.
- Participate in medical device hardware and software Design and Development Team meetings and activities as a member of the Team.
- Provide guidance in the interpretation of global regulations and standards.
- Create applicable design and development deliverables associated with the Design Assurance Quality Engineering function.
- Review all Design and Development deliverables to ensure compliance with the Product Development Plan, QMS and applicable regulations and standards.
- Provide leadership and understanding for Risk Management activities, ensuring Risk Management Files are kept up to date.
- Assist engineering in the compilation of design history files in accordance with ISO 13485, ISO14971 Risk Management and IEC 60601, IEC 62304, or applicable US-FDA and EEC-MDR regulations
- Assure all applicable quality decisions utilize risk management documentation as appropriate.
- Provide leadership, guidance and approval to V&V planning and related activities including suppliers as required
- Support Internal audits as a qualified auditor/lead auditor.
- Participate in change assessment activities through to Design Transfer and product launch.
- Participate in medical device software issue management activities throughout the product lifecycle.
Acquire and maintains current knowledge ofapplicable global regulatory requirements and trends; develops strategy andprovides internal guidance related to such trends.
· Assist on other projects and tasks asrequired.
· Conduct trainings and/or communicateappropriate materials, as needed, in order to enhance team’s/company’sknowledge of working in a regulated environment.
· Bachelor’s degree in life science orengineering.
· Minimum 5 years of medical device designassurance experience with medical device design and submissions for FDA ClassII or III medical devices.
· Experience reviewing mechanical, software andelectronics design requirements and specifications and working knowledge ofmedical device design controls
· Hands-on experience with medical devicehardware and software lifecycle processes and risk management includingverification and validation activities
· Working knowledge of FDA 21 CFR 820 and theEEC MDD/MDR.
· Proficiency with MS Office(Word/Excel/PowerPoint) and familiarity with PLM and QMS software tools.
· Excellent verbal, listening and written communicationskills.
· Ability to prioritize and plan workactivities, to problem solve, to adapt for changing conditions and to be a teamplayer.
· Excellent documentation skills includingrecord maintenance/tracking and an understanding of document traceability.
· Ability to work in a fast-paced teamenvironment under pressure to meet critical time frames as well as individuallywith minimal supervision.
Nice to Have:
· Experience in drug and device, patient monitorsystems, hospital-based products, software or respiratory products
· Degree in RA or Regulatory AffairsCertification a plus
· Management, leadership, and mentoring skillsand experience
· Familiarity with medical terminology a plus