Quality Design Engineer

Are you interested in progressing your career with a global leader in medical devices? Are you ready to challenge yourself in a fast-paced, highly-regulated environment? Are you an experienced Quality Engineer with technical expertise in quality remediation projects? You could be the perfect candidate for this opportunity! Don't hesitate, apply today!

Job Description

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

Benefits

• Competitive and attractive employee compensation package
• Pension contributions
• Health insurance
• Paid holidays

Location: Galway | Ireland

Desired Skills and Experience 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