Design Assurance

Real; Munster; On-site; EUR 83,000 - 129,000; Part time

Job summary

Real is seeking two experienced Design Assurance Contractors to support growing programme activity across R&D, Quality and Regulatory in Munster, Ireland. You will contribute to design controls, MDR Technical File remediation, risk management and the creation, review and approval of compliant design documentation for new product development, design changes and design transfer.

Ideal candidates have hands-on Design Assurance and Design Controls experience, ISO 14971 risk management, and

Qualifications

• Experience with Design Assurance and Design Controls
• MDR Technical File remediation experience
• ISO 14971 Risk Management
• DHF, Technical File and risk documentation
• Design Verification and Validation support

Responsibilities

• Support medical device programmes across new product development, design changes and design transfer.
• Contribute to Design Controls, MDR Technical File remediation, and risk management activities; create, review and approve compliant design documentation.

Skills

Design Assurance

Design Controls

MDR File Remediation

Risk Management

Documentation

Verification & Validation

Job description

A global medical device company is seeking two experienced Design Assurance Contractors to support growing programme activity across R&D, Quality and Regulatory. You'll support medical device programmes across new product development, design changes and design transfer. The role will focus on Design Controls, MDR Technical File remediation, risk management and the creation, review and approval of compliant design documentation.

Essential Skills

• Design Assurance and Design Controls experience
• MDR Technical File remediation experience
• ISO 14971 Risk Management
• DHF, Technical File and risk documentation
• Design Verification and Validation support

Desirable Skills

• Experience with ISO 13485 and Good Documentation Practice
• CAPA, non-conformance or audit support experience

This is a strong fit for Design Assurance contractors with a proven track record of remediation and compliance-led medical device projects who can work effectively across R&D, Quality and Regulatory teams.

Desired Skills and Experience

Design Assurance, Design Control, Medical Devices, ISO 14971, Risk Management, EU Medical Device Regulation, Technical Documentation, Design History File, Verification and Validation, ISO 13485, Quality Assurance, Regulatory Affairs, New Product Development, Product Development, Design Transfer, CAPA, Quality Management Systems, Failure Mode and Effects Analysis, Regulatory Compliance, Auditing, Corrective and Preventive Action, Medical Device Development, Engineering Documentation, Cross-Functional Team Leadership