Design Assurance Engineer

GxP Recruitment; Galway; On-site; EUR 45,000 - 65,000; Full time

Job summary

GxP Recruitment is seeking a Quality Engineer with 3-4 years in a STEM role, delivering technical input across R&D, Regulatory Affairs and Post Market Quality Assurance. You will ensure compliance with Design Control, Risk Management and surveillance requirements, while driving process quality and continuous improvements.

Strong teamwork, communication, and initiative are essential as you tackle complaints investigations, CAPAs, PIRs and regulatory changes in a fast-paced medical device

Qualifications

• HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 3-4 years' experience in a similar role.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.

Responsibilities

• Completes work assignments under limited supervision/guidance.
• Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
• Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
• Identifies and resolves complex exceptions to work assignments.
• Seeks to support improvements in product and process quality.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Excellent interpersonal and communication skills with good leadership abilities.
• Provides both quality and technical input to commercial product activities.
• Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
• Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
• Excellent analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
• Is an active team member completing quality deliverables associated with BSC's sustaining engineering (commercial product) support.
• Is a fully motivated team member - achieves and demonstrates best practices in line with set objectives.
• Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.

Skills

Technical capabilities

Communication skills

Teamwork abilities

Initiative

Education

HETAC Level 8 (240 credits) in a STEM discipline

Job description

Key Responsibilities

General

• Completes work assignments under limited supervision/guidance.
• Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
• Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
• Identifies and resolves complex exceptions to work assignments.
• Seeks to support improvements in product and process quality.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Excellent interpersonal and communication skills with good leadership abilities.

Technical

• Provides both quality and technical input to commercial product activities.
• Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
• Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
• Excellent analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.

Leadership

• Is an active team member completing quality deliverables associated with BSC's sustaining engineering (commercial product) support.
• Is a fully motivated team member - achieves and demonstrates best practices in line with set objectives.
• Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.

Qualifications & Experience

• HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 3-4 years' experience in a similar role.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.