What are the responsibilities and job description for the Quality Engineer II position at Katalyst CRO?
Job Description
Quality Engineer supporting MDR remediation and manufacturing quality for medical device products, focusing on process validation, risk management, and change control.
Responsibilities
Quality Engineer supporting MDR remediation and manufacturing quality for medical device products, focusing on process validation, risk management, and change control.
Responsibilities
- Execute process & test method validations (IQ/OQ/PQ).
- Perform First Article Inspections (FAI) and reporting.
- Develop PFMEA, Control Plans, risk assessments.
- Support MDR remediation activities.
- Conduct packaging/fit testing and validation.
- Review and approve change orders (Agile PLM).
- Perform label verification and production support.
- Collaborate with manufacturing, engineering, warehouse teams.
- 2 years Quality/Validation experience.
- Medical device experience preferred (MDR a plus).
- Bachelor's in Engineering (Quality/Mechanical/Biomedical/Industrial).
- Process Validation (IQ, OQ, PQ).
- Validation lifecycle (process characterization � PQ).
- Test method validation & documentation.
- PFMEA, Control Plans, risk documentation.
- FAI, dimensional inspection, manufacturing change evaluation.
- DOE experience (Minitab preferred).
- CSV (Computer System Validation).
- SOP development.
- Inspection sampling plans.
- Packaging validation.
- Change control (medical devices).