Design Assurance Engineer – Galway | Collins McNicholas

Design Assurance Engineer – Galway

  • Reference: GY45838AO
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing

Key Reponsibilities

Responsible for compliance of product development, risk management and post market activities

•  Work as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components.

•  Complete design verification, design validation and test method validation activities associated with product development and implementing design/process changes.

•  Work with R&D and manufacturing engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementing production monitoring and controls.

•  Resolve project issues by working with team members, suppliers, and others as appropriate. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.

• Monitor compliance with policies, procedures and applicable regulatory requirements, identifying and implementing process and system improvements.

•  Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA).

•  Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, and post market activities.

ESSENTIAL SKILLS / EXPERIENCE:

Minimum Bachelor’s Degree in Engineering, Science or related technical field, and a 3 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. The successful candidate will need a strong technical aptitude with an excellent understanding of their subject matter. Be highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.

KEY RELATIONSHIPS/ INTERFACES:

Regulatory, R&D, Clinical, Marketing, Operations, Distribution, External Services Suppliers

For a confidential discussion and more information on the role/company please  email your CV to: amy.oneill@collinsmcnicholas.ie


Firstname (required)

Surname (required)

Your Email (required)

Your phone

Upload CV (required)

Security Code captcha

Comment

Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
  • Connect with Amy

Job Seekers Guide

cmcn_hr_color
Everything you need to know to find a job, including; how to prepare a CV and cover letter, how to prepare for a job interview, how to navigate the modern job market, and much more.
view more