Posted on Feb 1, 2020 by LSA Recruit
Job Duties | Generic:
- Update risk documentation as appropriate
- Participate in cross-functional product improvement teams to identify and define product improvement opportunities
- May assist Product Engineering in a quality engineering support role, to include:
- Helping guide R&D through the quality system to ensure product changes are carried out in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies
- Reviewing and evaluating product change documentation for technical competence to ensure delivery of robust products changes
- Provide QA resource to product support to ensure regulatory compliance of post market products.
- Ensure that projects to develop medical devices follow applicable company policies, procedures, standards and regulations.
- Ensure that released devices are safe and effective and meet their intended use.
- Assist in production and market of product in investigating and reporting the results of investigations for reported technical problems as part of corrective actions.
- Manage auditing of internal and supplier quality systems to ensure effectiveness of the quality management system.
- Manage safety risks associated with medical devices in accordance with applicable standards.
- Help coach project teams on use of quality system.
- Assist in investigating and reporting the results of investigations for reported technical problems as part of corrective actions.
- To support quality control requirements, supplier quality, complaints, post market support, audit, non-conforming materials, CAPA systems and process risk.
Educational qualification required to perform the job
- Bachelor's degree, or 3 years equivalent work experience
Work Experience required to perform the job
- Hands on Experience to lead, develop, & implement strategy process improvements for process efficiency and corrective and preventive actions (CAPA program) effectiveness using a variety of Quality and Continuous Process Improvement tools.
- Participated in cross-functional product improvement teams to identify and define product improvement opportunities
- Review and approve all Quality related documents and validation documents.
- Assist in developing and executing a quality assurance program to include agent performance standards and workflow for the Contact Center
- Work closely with the QA Manager to provide guidance in applying the QA Program with QA/QC, field engineers, and project managers.
- Provide suggestions to ensure improvement in adherence to quality standards and improve overall team performance
- Assists in developing quality systems & make recommendations for improvements to existing Quality systems
- Communicate QA feedback issues to operations Team Leaders & Manager. Coordinate closely with team leaders and/or managers on quality performance management
Skills/Knowledge required to perform the job
- Exposure to ISO13485 and ISO14971 medical standards and have exposure to risk assessment techniques to evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
- Experience in test method development validation, development and transfer.
- Experience in stages of qualification like design, installation, operational and performance.
- Experience in preparing test plan documents and standard test method development.
- Experience in preparing manufacturing process control flow chart.
- Experience in Risk management and Change management process.