Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
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.
Requirements:
- 2+ years Quality/Validation experience.
- Medical device experience preferred (MDR a plus).
- Bachelor's in Engineering (Quality/Mechanical/Biomedical/Industrial).
Top Skills (Must Have):
- 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).