- The Quality Engineer works with minimal guidance to support the design, development, manufacturer and support of Diagnostic Reagents and Instrumentation. Responsibilities: May include some or all of the following:
Quality, Design Assurance
- Provide guidance to various internal functions and/or external partners on Quality System Practices as defined by company policies and procedures to ensure compliance to FDA, ISO/IVDR and European Medical Device quality standards and regulations.
- Participate in the new product development process which will include design assurance, risk analysis, risk management, product redesign and enhancements, as well as manufacturing transfer.
- In cooperation with Quality Compliance, initiate the risk management process for the instrumentation systems.
- Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to Good Manufacturing Practices within company. May act as an advisor to the teams based in Japan.
- Devise, implement, and conduct methods and procedures to validate software systems utilized to support the business.
- Perform Design History File audits and conduct independent review of product verifications and validations - systems, software, instrumentation, etc.
- Act as a Subject Matter Expert (SME) for instrumentation and manufacturing support as it relates to Quality. This includes assessing the impact of hardware and software changes submitted by company partners, contract manufacturers, and company.
- Lead problem-solving efforts (via 8D, 5 Why, Fish Bone, etc.) to identify and resolve quality or process challenges, as well as, compliance issues.
- Coordinate and/or conduct technical, external audits (critical suppliers, Third Party Manufacturers, global locations) as required.
- Provide support to the Technical Service teams - review of technical documents, complaints, etc., as provided from the Technical Service team. Determine what steps are necessary within the QMS to effectively manage feedback from the field service team.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Carries out duties in compliance with established business policies.
Quality, Compliance/Post Market
- Participate in complaint investigations and trending; document findings and provide reports and analysis. Recommend and implement corrective action and appropriate follow-up, as necessary.
- Conduct risk management activities and recommend an appropriate course of action via CAPA systems.
- Gather and report Key Performance Indicators (KPIs) - related to instrumentation system quality and reliability.
- Analyze quality data and information to identify trends and plans for their improvement.
- Analyze scientific literature to identify trends and plans for their improvement
- Maintain Design History Files.
- Collaborate with internal functions and SMD to complete post-market surveillance for instrumentation systems.
- Other responsibilities as required.
Education / Experience:
- Bachelor's degree in engineering or science related field.
- Minimum of 5+ years of experience in quality engineering with electromechanical systems and software, preferably in a medical device and/or diagnostics manufacturing environment.
- Expert knowledge and experience of the quality assurance system including Quality System Regulation 21CFR part 820 and the ISO 9000 series standards, ISO 13485, cMDR, JPAL.
Sthree US is acting as an Employment Agency in relation to this vacancy.