Quality Engineer II

Katalyst CRO; Dexter (MI); On-site; USD 70,000 - 100,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer focused on MDR remediation and manufacturing quality for medical device products. You will engage in process validation, risk management, and change control to ensure compliant production and reporting.

The role involves executing IQ/OQ/PQ validations, performing FAI, developing PFMEA and control plans, and supporting packaging validation. Collaboration across manufacturing and engineering teams is essential.

Qualifications

• 2+ years Quality/Validation experience.
• Medical device experience preferred (MDR a plus).
• Bachelor's in Engineering (Quality/Mechanical/Biomedical/Industrial).

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.

Skills

Process Validation

Validation lifecycle

Test method validation

PFMEA

Control Plans

Risk documentation

FAI

Dimensional inspection

DOE (Minitab)

SOP development

Inspection sampling

Packaging validation

Change control (MDD)

CSV

Education

Bachelor's in Engineering

Tools

Agile PLM

Minitab

Job description

Job Description

Quality Engineer supporting MDR remediation and manufacturing quality for medical device products, focusing on process validation, risk management, and change control.

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).