Design Quality Engineer
San Jose Metro Area, CA
The primary responsibility of this position is to assume a lead role in providing Quality Engineering support for New Product Development projects. The Design Quality Engineer is responsible for facilitating compliance to applicable internal and external requirements during the product development cycle and commercialization of new products.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
Design Control Activities. Be the design quality engineering resource for design projects:
o Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Control Process.
o Responsible for Quality Engineering deliverables required within the product development process.
o Support Design Verification and Validation activities, including review of verification & validation protocols and reports
o Assist in the analysis of product requirements and specifications. Participate in product design reviews and team meetings.
o Provide subject expertise and input in the following areas: Biocompatibility strategy, including requirements, protocol, and report; Shelf-Life Studies strategy, including accelerated and real-time; Cleaning Validation.
o Interface with all departments to provide leadership on the use of Quality Engineering methodologies, tools, regulatory compliance requirements.
o Lead / coach / guide engineers to facilitate compliance and to support process improvements.
o Ensure that technical information is accurate and in compliance with quality and regulatory requirements.
Risk Management Activities:
o Maintain and manage the overall Risk Management process in accordance with ISO 14791 and other applicable standards. Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure a comprehensive risk management process.
o Implement New Risk Management Process, Procedures, and Templates and help migrate and update current risk management documents to new process.
o Manage Post-Market Surveillance and Feedback into Risk Management
o Implement new Usability Process, Procedure and Templates and provide support to the transition to new Usability processes.
o Provide quality support for the Usability plan, report, and file.
Implement Design Control process improvements to ensure a more effective, efficient, and compliant design control process.
DHF Audits throughout the development process
Development of Quality Plans
Maintain and Manage the DHF after product commercial release
Ensure that technical information is accurate and in compliance with international regulatory requirements.
Perform all duties with minimal oversight required from direct manager.
Additional responsibilities include: generating and revising relevant procedures, preparing and analyzing quality trend data, supporting the resolution of CAPAs to closure and verification of effectiveness, and participation in internal and external audits.
Bachelors degree in science or engineering.
Minimum of 7 years of quality engineering experience in an FDA regulated medical device manufacturing environment.
Advanced knowledge of, and proficiency with medical device development life cycles and Design Control processes.
Ability to handle complex issues and exercise judgement, based on experience, with minimal oversight from manager.
Knowledge of QSR, ISO 13485, and ISO 14971
Knowledge of IEC 62366, IEC 60601, Biocompatibility, and Aging Studies preferred
Ability to write Verification / Validation protocols and reports.
Six sigma green belt preferred.
Competent using office software including MS Word, Excel, PowerPoint, and Outlook.
Responsible for performing all duties in compliance with FDA s Quality System Regulation (QSR), ISO13485, ISO 14971, the Canadian Medical Device Regulations, and all other international regulatory requirements with which the company complies.
Knowledge of IEC 60601 and software validation, is one of the most important requirement that we must see in all submitted qualified candidates.