Quality and Compliance Manager

Company Description

Opera Beds is an established, fast-growing, family-owned business specialising in providing care beds and mattresses to care homes, trade retailers and consumers at home. Opera operates in the UK & Ireland and more recently USA.

Purpose of the role

We’re looking for a hands‑on Quality & Compliance Manager to take ownership of product compliance, quality systems, and regulatory documentation across our product range. You will manage technical files, oversee compliance with UK, EU and US regulations, and keep our quality management systems operating effectively.

If you’re confident with standards such as UKCA, CE, MHRA, FDA, and experienced with ISO9001/14001, this role gives you the platform to lead the compliance function and prepare the business for ISO13485.

Key Responsibilities, but not limited to:

• Ownership and management of Product Technical Files.
• Ensuring product compliance with UKCA, CE, MHRA, FDA, and other US labelling requirements.
• Managing and updating product Instructions for Use (IFUs) to meet regulatory standards.
• Creating and managing product testing schedules to ensure all products meet internal and external requirements.
• Operating, maintaining, and improving the ISO9001 Quality Management System and ISO14001 Environmental Management System.
• Leading the scoping and preparation work to position the business for ISO13485 certification.

Remuneration:

• Competitive Salary
• Profit Share Scheme
• 23 days holiday (plus 8 days bank holidays)
• Bonus birthday holiday
• Private Health scheme option
• Full time – 8pm – 4.30pm daily
• Location : Hybrid

If you want to take ownership of compliance in a growing business and shape the next stage of our quality systems, we’d like to hear from you.