Collins McNicholas

Technical Quality Manager

An exciting new role has come up at an expanding healthcare site driven by new products with high demand on the global market. As Technical Quality Manager, you will have responsibility for The main responsibility of leading a team of Quality Engineers, primarily in the areas of Validation and Technical Quality, ensuring the site delivers safe and effective products that meet customer needs whilst maintaining regulatory compliance.  Reporting to the Quality Director, you will have responsibility for implementing Quality objectives and ensuring short term and long term quality goals are met.

Major Responsibilities:

  • Ensure validation and qualification activities of processes, methods, and equipment comply with internal requirements and applicable regulations and standards.
  • Assume responsibility for the Quality department in the absence of the Department head.
  • Develop continuous improvement plans and activities as related to Validation and testing processes.
  • Assist in the development and implementation of company-wide quality systems and policy compliance to FDA QSRs, ISO13485, MDR and IVDD.
  • Oversee the management of the site-wide calibration systems to ensure equipment is in compliance for use.
  • Manage the quality department staff, their training and development to support incoming, in-process inspection, final inspection, and release.
  • Analyze product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly.
  • Develop key quality metrics/indicators to track performance and compliance and analyze data to develop and implement improvements.
  • Review and approve the investigation of non-conformances associated with non-conforming products, out of specifications (OOS), audit findings, and customer complaints.
  • Support the Engineering Change Control process by reviewing and approving ECs, ensuring compliance with internal compliance and applicable quality and regulatory requirements.
  • Ensure that Product Design changes are transferred into manufacturing according to ADC policies and procedures. 
  • Promote Continuous Improvement within the department using tools such as Performance Excellence review and Growth Plans.

Minimum Education Required:

  • A relevant third level qualification in Engineering/Manufacturing/Science.

Minimum Training/Experience Required:

  • 5 years of relevant experience in a similar environment preferred
  • Supervisory experience preferred

Attractive remuneration package on offer as well high potential of advancement to a senior leadership team role in the future.

******************************************************************************

For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

First Name

Surname

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