Quality Engineer

Creative Solutions Services, LLC; Lexington (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in Massachusetts is seeking a Quality Engineer to ensure catheter and console products and design changes meet regulatory and quality requirements through development, transfer to manufacturing, and post-market support.

You will collaborate with cross-functional teams across the product lifecycle, lead investigations of complaints and CAPA, perform risk analysis, design controls, and verification and validation activities for sterile disposable medical devices

Qualifications

• Experience in the Medical Device industry is required.
• 3+ years of experience in quality engineering.
• Experience with design controls and risk management.
• Experience with catheter or sterile disposable products is preferred.
• Familiarity with CAPA systems and complaint investigations.
• Knowledge of IQ/OQ/PQ and Process Validation.

Responsibilities

• Ensure catheter and console products and design changes meet regulatory and quality requirements throughout the design, development, and manufacturing transfer process.
• Collaborate with cross-functional teams; participate in all phases of the product development process.
• Include development, reliability testing, design controls, input requirements, early design feasibility testing and verification and validation, manufacturing process development, product risk management, and delivery.

Skills

CAPA

Complaint investigations

Nonconforming material evaluation

Design controls

Risk analysis

FMEA

Catheters/sterile disposables

IQ/OQ/PQ

Sustaining engineering

Medical Device industry

Job description

Responsibilities:

• This role will be responsible for ensuring the new catheter and console products and design changes to existing products meet regulatory and quality requirements throughout the design, development, and manufacturing transfer process.


• This will be accomplished through close collaboration with cross-functional teams. The Quality Engineer participates in all phases of the product development process.


• This includes development, reliability testing, design controls, input requirements, early design feasibility testing and verification and validation, manufacturing process development activities, product risk management requirements, and delivery.

Requirements :

• Medical Device industry.


• 3+ years of experience.


• Complaint investigations.


• CAPA's.


• Evaluating nonconforming material.


• Experience with catheters or sterile disposables.


• Process Validation, IQ/OQ/PQ.


• Design Control.


• Risk Analysis.


• FMEA.


• Sustaining engineering.