Quality Manager (QA and RA Manager)

We really appreciate you taking the time to read through this job advertisement, and we know our clients do too. 

Talking of our clients, we wanted to let you know a bit about them before you jump into looking at the job opportunity.  We partnered with this organisation in late 2019 to early 2020 and have a great deal of conversations and discussions about who they are and what they do.  For example, this business is 20+ years old, and yet small enough to feel like a family run business.  They dominate in their field of CMO manufacturing for a huge variety of industries.

This company has a great team, great drive and great passion for what they do and they are actively pursuing growth potential for this company to launch their name amongst their competitors and really drive companies towards using their manufacturing services.

As with all change, they need the next level of guidance and support, from someone who really understands the industry.  That’s why they need YOU!

They are looking for a hands-on QA Manager who can help them by managing the QMS and ensuring the company is in compliance with all their respective requirements.  Read below to see what your responsibilities would likely be:

ROLE

• Maintain and Improve the Existing Quality Management System (QMS)
• Promote Quality and Continual Improvement within the company
• Work closely with the business owners to discuss Quality strategy and Quality improvement suggestions
• Understand the relevant Regulatory Intelligence and convey this to the wider company
• Work in a dual function, supporting regulatory affairs around the business (primarily to share the understanding of regulatory requirements surrounding Medical Devices)

REQUIRED (Essential)

• 2-5 years within Quality Assurance (preferably for a Medical Device company)
• Experience working autonomously or the ability to do so
• A higher level qualification in a scientific discipline
• Excellent understanding of ISO 9001 and ISO 13485

REQUIRED (Preferred)

• 1-2 years within Regulatory Affairs for a Medical Device company
• Lead Auditor and Lean/Sigma Qualifications
• Previous Line Management Experience

REMUNERATION

• Basic Salary of £40K - £45K Per Annum

RESPOND

• Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV