Design Assurance Engineer II

HERO

Job Detail

Location Galway Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Katie Kilbane
email network@hero.ie

Design Assurance Engineer II

Apply Now

Job ID: JOB-12940

Design Assurance Engineer II

Job Purpose

As the newest member of the Design Assurance team, you will demonstrate commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system. The key to the success of this function is to fulfil the quality assurance responsibilities of our clients’ new product development and post-market (commercial product) support, including the application of Design Controls in Product Development and Sustaining Changes to ensure that all design changes are compliant with associated Regulations and Methods. 

We are looking for individuals that share our clients’ passion for innovation and advancing solutions for some of the world’s most challenging healthcare issues.   

 

Key Activities of the Role:

General

  • Completes work assignments under limited supervision/guidance.
  • Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management face 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.
  • Evaluate trending and product performance to support site-level Signal Evaluation Reviews and Complaint Review Boards
  • 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 ongoing product development and post market 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 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 new product development and post market (commercial product) support.
  • Coaches others in areas of expertise. Gives technical guidance to junior team members. Uses opportunities in project assignments to develop self & others.
  • 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 and Experience:

 

  • NFQ Level 8 qualification in a STEM discipline
  • Minimum of 3-4 years experience in a must
  • Experience in post-market (complaints) support, risk management, design and process change, and standards compliance (to regulatory requirements) is highly desired.
  • Good technical capabilities, communication skills, teamwork abilities and initiative
  • Proven ability to work well both as part of a team and work on your own with minimum supervision

 

For further information on this role please contact Katie Kilbane on 086 1283368 / network@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Katie Kilbane

JOB-12940

Apply Now

Design Assurance Engineer II

Katie Kilbane

Role Type Permanent
Contact Katie Kilbane
email network@hero.ie
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