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Atlantic Therapeutics

Product Quality & Quality Assurance Engineer

Atlantic Therapeutics

  • Galway
  • Negotiable
  • Permanent full-time
  • Updated 03/11/2017
this job is expired
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Atlantic Therapeutics is a growing organisation with an exciting new product that changes people’s lives.  We are building a team of people with the belief, passion and expertise to make our business a success and positively influence our customer’s quality of life.  Our vision is to enable millions of people each year to restore their pelvic floor, and thereby restore their control, confidence and active lifestyle.


Job Title: Product Quality & Quality Assurance Engineer (PQE /QA)

Responsible for the ongoing management & development of product manufacturing & quality programs with Atlantic Therapeutics’ sub contract manufacturing partners for new and existing products, ensuring that AT’s internal quality system for process and product controls is in compliance with ISO 13485 and FDA Quality System Regulations. This role will also support the implementation and improvement of AT’s Quality Management system.


What’s important:

  • Working experience of a certified Quality Management System

  • Working experience of managing external suppliers, preferably with external Quality Auditor training

  • Document control and engineering change management experience

  • Knowledge of handling customer complaints

  • Knowledge of regulatory processes for EU and FDA product clearance

  • Some flexibility to travel to Asia / Europe to manage Sub suppliers (circa 10% - 15% of time is travel)


The day to day:

  • Implementation and oversight of Supplier Quality Management plans / agreements, including review, supplier audits, issue resolution and scorecard based supplier performance management.

  • Development and maintenance of Quality Management programs aimed at optimising process and product quality with sub-contractors and other suppliers, including supplier visits as needed.

  • Provide technical & quality support during transfer of products and associated technology from design to sub-contractors including PQP development / process qualification & validation and production support including qualification.

  • Manage customer complaints process with specific responsibility for product related issues including investigation, root cause analysis, corrective action and customer feedback.

  • Create top level part numbers and develop BOM’s.

  • Support CCO, sample, CoC and deviation processes for the supply base.


Where you’ve come from:

We would like you to have a third level degree and a post-graduate qualification in Quality Assurance would also be an advantage.  You will have a significant amount of experience in medical devices or other similarly regulated industry with a certified quality management system. 


Who you are:

  • A team player with excellent communication skills.

  • Knowledge of applicable quality systems for medical devices.

  • Experience of electronic manufacturing process with supplier auditing experience.  

  • In depth knowledge of maintaining a certified Quality Management System

  • Knowledge and application of Quality tools and methodologies including lean six sigma, TQM etc.

  • Experience of EN/MDD, ISO13485 and FDA requirements

  • Strong attention to detail

  • Results orientated and a self-starter with the ability to work on own initiative

  • Knowledge of and commitment to continuous improvement and problem solving

  • Advanced Microsoft Office and reporting tool skills

  • Strong project management skills

Ref: PQE17
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Atlantic Therapeutics

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