Design Assurance Engineer

Our client in Galway are seeking an experienced Design Assurance Engineer to join their team and fulfil Quality Assurance responsibilities as part of a quality remediation initiative. The position will focus on ensuring robust application of design controls, risk management, and test method validation.

Key Responsibilities

· 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.

Key Requirements

· HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 2-4 years’ experience in a similar role.

· Experienced 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.

· Proven ability to work well as part of a team & on own with minimum supervision

DHF Experience required

Medical Device Background

12 Months Fixed Term Contract with an extension

Full time onsite

Location - Galway

Salary

Pension

Healthcare

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