Quality Engineer IV #JN -062021-65091
Posted on: June 4, 2021
Industry: QA Testers
Job Number: JN -062021-65091
- This is a hands-on position, which the right candidate will be able to adapt quickly to changing priorities and manage the integration activities within the Aesthetics business.
- The ideal candidate will provide support to the Quality Operations team to maintain compliance during the integration activities.
- Manage multi discipline groups for project execution and implementation
- Serve as an owner of the QMS integration activities for one of the Aesthetics sites.
- Responsible for the completeness of the integration activities; Create, review, and approve controlled documents on an electronic document control system.
- Coordinates and/or provides training to staff in Quality System documents, work instructions.
- Provides ongoing development and maintenance of training materials and records during integration activities.
- Review and assess QMS changes for completeness, accuracy, and effectiveness.
- Collaborate with the team to define and implement systems that enhance efficiency, productivity, and quality;
- Work towards resolving quality issues
- Ensure that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes and global QMS processes;
- Maintain and update the integration plan
- Recognize areas for continuous improvement
- Perform other duties as may be required by management.
Minimum Qualifications, Skills, and Abilities:
- Bachelor’s Degree in Engineering.
- 5+ years of experience within the medical device space, R&D, regulatory or design development.
- Effective verbal and written communication skills; ability to write clear procedures
- Exhibit good problem solving and analytical skills
- Proficient in the use of Microsoft Office
- Knowledge in FDA QSR, ISO 13485 regulations
- Knowledge in Root Cause Analysis tools
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