Design Assurance Engineer – Medical Devices, Risk & Verification

Oxford Global Resources; Galway; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Oxford Global Resources in Galway seeks an experienced Design Assurance Engineer to support a quality remediation initiative, focusing on design controls, risk management, and test method validation within a medical device environment.

You will collaborate with R&D, Regulatory Affairs and Post Market QA, review DHF records, validate verification strategies, and help ensure transfers comply with internal and regulatory requirements. 12-month fixed term with potential extension.

Qualifications

• HETAC Level 8 (240 credits) in a STEM discipline with 2–4 years’ experience in a similar role.
• Experience in risk management, design and process change, standards compliance (to regulatory requirements).
• Practical knowledge of 13485 and FDA part 820.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• DHF Experience; Medical Device Background.

Responsabilités

• Interface with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
• Review core DHF records.
• Evaluate verification strategies to confirm that approved TMVs are in place and align with global work instructions.
• Familiarity with requirements and procedures that govern medical device Design Control.
• Understanding of Design Assurance requirements to ensure new product/technology transfers comply to all internal and regulatory requirements.
• Identify and resolve complex exceptions to work assignments.
• Seek to support improvements in product and process quality.
• Provides both quality and technical input to ongoing product development and post market commercial product activities.

Connaissances

Risk management

Design controls

Regulatory knowledge

Quality assurance

Teamwork

Formation

HETAC Level 8 in STEM

Description du poste

Oxford Global Resources in Galway seeks an experienced Design Assurance Engineer to support a quality remediation initiative, focusing on design controls, risk management, and test method validation within a medical device environment.

You will collaborate with R&D, Regulatory Affairs and Post Market QA, review DHF records, validate verification strategies, and help ensure transfers comply with internal and regulatory requirements. 12-month fixed term with potential extension.