Collins McNicholas

Role Responsibilities:

  • Establish, maintain and continuously improve the company’s quality systems, procedures and policies
  • Maintain design history files in accordance with the company’s product development process
  • Liaison with the Notified Body, FDA and Competent Authorities as required
  • Lead CAPA related activities and associated tasks.
  • Manage company’s preventative maintenance and calibration schedules and plans.
  • Ensure product inspections take place in line with company procedures, manage any Deviations, NCPs or MRBs which may arise.
  • Prepare for and document company meetings such as Management Review, Post Market Surveillance and Quality Monthly Meetings.
  • Manage task completion as they arise from company meetings.
  • Trend all Quality Data as required, identify and implement changes or improvements to existing systems.
  • Manages, plans and documents all routine product testing to ensure continued compliance of products
  • Management of Internal auditing programs and vendor management activities including critical vendors audits
  • Act as management representative with responsibilities as outlined in ISO 13485, clause 5.5.2
  • Manage and drive project tasks to ensure timely completion of QMS project milestones.
  • Support regulatory affairs activities in support of medical device product development, including clinical, preclinical, and marketing issues
  • Monitor global regulatory/quality system changes, guidelines or trends, complete gap analysis plan, advise or implement changes to ensure compliance.
  • Lead the integration of the EU MDR requirements into the existing ISO 13485 Quality Management System.


Role Requirements:

  • Degree qualified with a minimum of 10 years’ experience in quality role of a medical device company
  • Established understanding and track record of ISO 13485, 21CFR820, ISO 14971 and MDD93/42/EEC
  • Ideally have knowledge of requirements of the new European Medical Devices Regulations (EU-MDR), Regulations (EU) 2017/745.
  • Lead auditor certification (IRCA or ANAB)
  • Experience of clinical trials or clinical investigations would be beneficial
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem solving, oral and written communication skills
  • High level of self-motivation and detail oriented to deliver assigned tasks
  • Ability to work as part of multi-disciplinary team of clinicians, engineers and senior management


For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email

First Name


Your Email (required)

Your mobile (required)

Preferred Collins McNicholas Office (required)

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

5 Brilliant Benefits of Temping!

Benefits of Temporary Contracts Blog
Accepting temporary contracts can be an excellent way of earning an income. Whether you are on holidays from college or ‘in between jobs’, there are plenty of benefits to temping:   CV Regardless of how long a contract is, all jobs bring new and fresh experiences to your CV. Temping is a great way to upskill […]
Read More

Biopharma Report

biopharma biopharmaceuticals industry report
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More
  • Find a job
  • Apply
  • Get a job