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
DHF Experience required
Medical Device Background
12 Months Fixed Term Contract with an extension
Full time onsite
Location - Galway
Salary
Pension
Healthcare
Holidays