Connecting to LinkedIn...

Vacancy Details


105315 - R&D Quality Specialist - Mayo

Contract Type: Permanent
Location: Mayo
Date: 2/10/2019
Job Reference: 105315
Contact Name: Bimi Felix
Contact Email:

Job Description

R&D Quality Specialist - Mayo - 105315

R&D Quality Specialist / Design Assurance Mayo

Our client, a medical device company in Mayo are currently looking to recruit a R&D Quality Specialist / Design Assurance Engineer for their site.

Role Summary
The R&D Quality Specialist will provide day to day assistance for Clinical Trial Supplies QA activities
ensuring assigned tasks are performed in a timely manner to meet Clinical supply requirements.

The R&D Quality Specialist is involved in the review /and or approval of elements of the quality system for Global
Clinical Supplies Westport including:
• Deviation management
• Change Control Program
• Self-Inspection
• Complaints Management
• Preparation and presentation of Monthly Metrics and Quality Management Reviews
• Preparation and coordination of Annual Mock Recall
• Review of semi-finished batch paperwork
• Review of Clinical Packaging batch records (pre and post approvals)
• Receipt and Release of Clinical Trial components
• Label Design Approvals
• Item Master Approvals
• Managing storage of batch documentation for Global Clinical Supplies Westport
• Management of the Temperature Excursion Process
• Management of Product Specification Files
The R&D Quality Specialist is accountable for their individual areas of responsibility within the company Pharmaceuticals Ireland quality system. The position holder must show the competence to drive forward the quality processes at the site and the skills to ensure that Compliance adds to the greater benefit of the facility. In association with the Quality Manager will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and Regional Ministries of Health.


This is a list of Core Duties and must not be taken as a definitive list. You may be asked form time to time to undertake other duties, either in or out of your area of responsibility
1) People
• Maintain strong relationships with management and colleagues in the Global Clinical Supplies Departments at Westport and Sunrise and with Clinical personnel at Marlow. Articulate the necessary requirements in a clear, concise and persuasive manner.

2) Strategic
• Work with the Quality Manager on the delivery of the company quality plan and global regulatory requirements for the site
• Manage quality requirements for process changes and new clinical studies as deemed necessary
• Ensure effective recording, analysis and reporting of KPI’s ensuring issues impacting quality performance are addressed and drive continuous improvement.
• Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program.
• Represent the company in Ministries of Health inspections as required.

3) Management
• Provide quality input as required, providing direction on day to day activities as a member of the site quality team
• Foster an environment of continuous improvements for the Compliance area by identifying and implementing efficiencies and quality improvements
• Support process changes/validation projects where Compliance services are required

4) Administration / Meetings
• Coordinate GTW Management for area of responsibility
• Preparation and review of semi-finished batch paperwork
• Review of Clinical Packaging batch records (pre and post approval)
• Label Approvals
• Item Master Approvals
• Receipt and release of Clinical Trial components
• Coral Review and Approval of assigned documentation as deemed necessary
• Coordinate GCS quality monthly meetings for assessment of quality system performance
• Assist in the preparation and management of site MOH and customer inspections
• Management of Temperature Excursion Process
• Management of Product Specification Files
• Management of Annual Mock Recall
• Review and approval of GTW records and associated documentation
• Complete assigned internal and external audits
• Attend all routine meetings as required. For example: Daily team meetings, metrics meetings, Quality Management Review, Study Planning meetings, GTW meetings

• Proven track record in a quality discipline in the Pharm/Medical Device environment.
• Third Level Science qualification
• Clear understanding of working within a regulated environment
• Excellent communication skills
• Ability to use sound judgment to make effective decisions within appropriate timeframes
• Proven to be self-directed, self-motivated and ability to prioritise competing priorities.
• High level of self-integrity and ethical conduct

• Relationship Building: establishing excellent working relationships with all functions within PDQA.
• Communication: excellent communication and presentations skills, both written and oral – Articulate the quality requirements in a clear, concise and persuasive manner.
• Planning & Organising: excellent analytical skills. Ability to plan and schedule.
• Decision Making: identify and understand issues, problems and opportunities whilst providing a viable solution.
• Adaptability; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
• Passion for results: - Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
• Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.

Other requirement (i.e travel)
• Undertake any training or travel that the role may require, including the completion of quality inspections of third party facilities as required.

For further information on this R&D Quality Specialist role in Mayo please contact Bimi on 086 8395533 /

Check out all our open jobs on our HERO Recruitment website –
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Share this Job

“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 

Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems

Clients we are proud to work with