QA QMS Specialist / Ireland

QA QMS Specialist - Global Biopharmaceutical Organisation - Contract - Ireland

A global biopharmaceutical organisation focused on developing life-changing therapies for people living with rare disorders are currently looking for an experienced QA QMS Specialist for a contract position based on the east coast of Ireland.

The ideal candidate will be educated to degree level, preferably in a Science or similar field, and bring demonstrable experience from within the Medical Device/ GMP / Regulated Industry.

You will be adept at assessing Quality Management System elements and their interdependencies. 

You will be a natural communicator, whether this be written or verbal, and be comfortable working in a fast paced and dynamic environment.

Key responsibilities of the Quality Engineer (QMS):

• Working with key stakeholders and within the QMS team, play a pivotal role in leading relevant departments in developing and implementing a Quality Management System based around ISO 13485, 21CFRPart4, and EUMDR.
• Be the Subject Matter Expert regarding Acceptable Quality Standards for processes.
• Support the company by helping review and approve necessary Procedures, Work Instructions, Forms and training.
• To help develop a culture of continuous improvement within the Company.

Experience:

• A degree in a relevant engineering, design or science discipline (or equivalent qualification)
• Appreciation for all stakeholders involved in new product development
• 4+ years’ experience in a highly regulated environment          
• Developing and improving Quality Management Systems and the ability to interpret regulations
• Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820, and cGMP
• Experience auditing to ISO 9001 or ISO 13485 would be an advantage
• Experience in product development and the application of Design Controls would be an advantage
• Ability to lead and influence

Please apply NOW for more information!

The candidate must have the rights to work in the location stated in the job advert.

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