Quality Engineer II

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).