Director of Quality

Spencer Rigby Ltd.; Oxford; On-site; GBP 90,000 - 150,000; Full time

Job summary

Spencer Rigby Ltd. is seeking a Director of Quality to own quality for its high-volume sterile consumables segment. You will span five sites across the UK and international locations, setting the standard for quality and driving improvements from factory floors to patients.

Lead a team of Site Quality Leads, collaborate with Operations, Commercial and R&D, and travel regularly to manufacturing sites. A strategic, data-driven leader with strong regulatory insight will succeed in this role.

Qualifications

• Senior quality leadership in medical device manufacturing.
• Hands-on sterile manufacturing experience, including sterilisation and sealing processes.
• Calm, decisive approach to CAPAs and field actions balancing patient safety, regulatory risk and business impact.
• Ability to influence and lead across countries and cultures.
• Experience leading teams across multiple sites and countries.

Responsibilities

• Own product quality for the high-volume sterile consumables segment.
• Lead five Site Quality Leads across the UK, Europe and the Americas.
• Set and enforce quality standards across five sites.
• Drive CAPA programs and field actions with regulatory risk awareness.
• Collaborate with Operations, Commercial and R&D; travel regularly to where products are made.

Skills

Quality leadership

Cross-site leadership

CAPA management

Regulatory compliance

Sterile manufacturing

Data-driven decisions

Tools

ISO 13485

FDA inspections

CAPA system

Job description

A PE-backed global MedTech has grown quickly through acquisition, bringing together businesses that each joined with their own way of doing quality. We’re looking for a Director of Quality to own product quality for its high volume sterile Consumables segment.

You’ll own quality for an entire product segment, with the authority to set the standard every site works to. It’s your job to bring five sites together under one way of working, use the data to catch problems before they reach patients, and focus the team on changes that make a real difference.

You’ll lead 5 Site Quality Leads across the UK, Europe, the Americas, reporting to the VP of Global Quality. You’ll have real influence with Operations, Commercial and R&D, and you won’t be tied to a desk at one site. You’ll spend your time where the products are made.

What we’re looking for:

• Senior quality leadership in medical device manufacturing, including leading teams across multiple sites
• Hands-on sterile manufacturing experience, including sterilisation and sealing processes
• A calm, decisive approach to CAPAs and field actions, able to balance patient safety, regulatory risk and business impact
• The ability to influence and bring people with you, including those who don’t report to you
• Experience leading teams across different countries and cultures
• Working knowledge of EU MDR, FDA, Notified Body audits and ISO 13485
• Based in the UK, with regular international travel
• High volume, multi-site manufacturing
• Ophthalmic/ eye care/ vision MedTech experience

This is a segment-level leadership role in a growing business with the investment and leadership support to back real change. You’ll have a clear remit, a team of site leaders across five countries, and visible impact from the factory floor to the surgeons and patients who rely on the products.