What are the responsibilities and job description for the Quality Engineer position at Innovative Health LLC?
The Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will have responsibility for identifying and driving improvements related to quality, compliance to regulatory requirements and business efficiencies within the Quality Organization.
- Supports the Corrective and Preventive Actions Program by monitoring the system and completing investigations and implementing actions as applicable.
- Supports Calibration and Preventative Maintenance systems
- Represents and provides quality support for new product development initiatives.
- Verifies and validates design and processes utilizing IQ, OQ, and PQ process.
- Develops and writes test methods.
- Creates documentation for manufacturing, quality control, and final release processes.
- Generates formal test protocols and reports.
- Supports continuous process improvements through detailed data analysis.
- Provides documentation and support for the submission of FDA 510Ks.
- Participates in risk management activities for product and process design projects including PFMEA risk assessments.
- Reviews and approves complaint investigations.
- Conduct data analysis using Minitab or equivalent statistical software.
- Train manufacturing / QC personnel as needed on test methods or manufacturing processes.
- Document test results per GDP, ISO and FDA requirements.
- Participates in process improvement projects to reduce costs.
- Assists with environmental monitoring of production facilities and equipment.
- All other duties, as assigned.
Education and Qualifications :
