Head of Quality Assurance - Operations

Corin Group; Cirencester; On-site; GBP 84,000 - 94,000; Full time

Benefits offered by this job

Competitive salary

Discretionary bonus

Pension

Private medical insurance

Eye tests

Flu vaccinations

Job summary

Corin Group seeks a senior Head of Quality Assurance - Operations to provide strategic and operational quality leadership across manufacturing and supply activities. You will champion QA in day-to-day operations, drive continuous improvement and ensure compliance with the Quality Management System and regulatory requirements.

The role requires extensive experience in regulated manufacturing, leading quality teams, and managing supplier quality.

Qualifications

• Degree in Engineering, Science, Quality Management or related field.
• Minimum 10 years of senior Quality experience in regulated manufacturing.
• Strong knowledge of ISO 13485 and medical device regulations.
• Proven leadership of Quality teams in manufacturing and supply chain.
• Experience with CAPA, investigations and continuous improvement programs.

Responsibilities

• Lead QA Operations across Manufacturing, Supply Chain and QA teams.
• Set objectives, priorities and accountability for quality performance.
• Ensure quality issues are identified, investigated and addressed at source.
• Develop and monitor operational Quality KPIs and metrics.
• Support internal, supplier and regulatory audits and inspections.
• Lead Supplier Quality activities and qualification processes.

Skills

Quality leadership

Stakeholder management

Analytical skills

Communication

Change leadership

Education

Engineering/Science/Quality degree

Tools

CAPA system

QMS/document control

Job description

Reports to: Global Director, QA, RA & Clinical

Lead Quality Excellence. Drive Operational Performance. Protect Patient Outcomes.

At Corin, we are passionate about improving the quality of life of patients through innovative orthopaedic solutions. As we continue to grow and evolve, we are seeking an experienced Head of

Quality Assurance - Operations to provide strategic and operational Quality leadership across our manufacturing and supply activities.

This is a critical leadership role responsible for ensuring products are manufactured, inspected, released and supplied in full compliance with Corin's Quality Management System (QMS), applicable regulatory requirements and internal quality standards.

As a key member of the Quality Leadership Team, you will act as the senior Quality representative for Operations and Supply Chain, partnering closely with Manufacturing, Engineering, Regulatory Affairs and global Quality colleagues to embed quality into everyday operations while supporting business performance, product availability and continuous improvement.

You will also deputise for the Global Director QA, RA & Clinical on operational quality matters as required.

Quality Operations Leadership

• Lead and develop the QA Operations function, setting clear priorities, objectives and accountability.
• Act as the senior Quality representative for Manufacturing, Supply Chain and operational activities.
• Ensure quality issues are identified, investigated and addressed effectively at source.
• Ensure appropriate Quality resource planning to support manufacturing output and business priorities.
• Develop and monitor operational Quality KPIs and metrics to drive performance and continuous improvement.
• Support internal audits, supplier audits, customer audits and regulatory inspections.

Quality Control & Inspection

• Lead the Quality Control and Inspection teams, including incoming goods inspection and final product inspection activities.
• Maintain effective inspection methods, specifications, acceptance criteria and quality records.
• Drive risk-based inspection strategies, utilising process capability and historical performance data to optimise inspection levels.
• Develop team capability through training, competency assessment and succession planning.
• Lead Supplier Quality activities across suppliers and contract manufacturers.
• Ensure supplier qualification, monitoring and performance management activities are aligned to risk.
• Drive a risk-based approach to incoming inspection and supplier controls.
• Support supplier audits and regulatory assessments relating to supplier controls.

Manufacturing Quality Support

• Provide Quality leadership to manufacturing and operational teams.
• Support investigations, containment activities, process changes and production issues.
• Collaborate with Manufacturing and Engineering teams to resolve recurring quality concerns and deliver improvements.
• Promote risk-based decision‑making throughout operational activities.
• Support process improvement, validation and scale‑up initiatives while maintaining regulatory compliance.

Nonconforming Product & Concessions

• Lead the management of nonconforming products, including investigation, disposition and escalation activities.
• Ensure product impact and regulatory considerations are fully assessed.

Validation, Packaging & Labelling

• Provide Quality oversight for manufacturing and process validation activities.
• Ensure Quality involvement in equipment, process and inspection‑related validation programmes.
• Support packaging and labelling activities, including implementation of approved changes.

About You

We're looking for a confident and collaborative Quality leader with substantial experience operating within highly regulated manufacturing environments.

• Degree qualification in Engineering, Science, Quality Management or a related discipline, or equivalent industry experience.
• Minimum 10 years' senior Quality experience within the medical device industry or another highly regulated manufacturing sector.
• Strong working knowledge of ISO 13485 and applicable medical device regulatory requirements.
• Proven experience leading Quality teams within manufacturing and supply chain environments.
• Strong understanding of risk-based Quality Management and application of Quality controls across manufacturing and supplier processes.
• Demonstrated experience managing investigations, nonconformances, CAPA and continuous improvement programmes. Experience supporting audits, inspections and regulatory assessments.
• Experience with validation activities, packaging and labelling processes.
• Understanding of sterilisation processes.
• Experience with outsourced manufacturing and supplier management.

Personal Attributes

• Pragmatic and commercially aware while maintaining the independence and integrity of the Quality function.
• Strong analytical and problem‑solving capability.
• Excellent communication and stakeholder management skills., with ability to engage effectively with operators, technical specialists, auditors, suppliers and senior executives.
• Comfortable challenging established practices and leading change.
• Highly organised with strong prioritisation skills.

Why Join Corin?

At Corin, you'll play a pivotal role in ensuring the quality, safety and effectiveness of products that help improve patients' lives around the world. You'll join a collaborative leadership team, influence strategic decisions and have the opportunity to make a lasting impact on operational excellence and quality culture across the organisation.

• A competitive salary between £84,000 - £94,000 dependant on experience and a discretionary annual bonus
• Excellent pension – starts at 6%, going up to 9.7% after 18 months.
• Life assurance – Six times your basic salary
• Private medical insurance with BUPA for you and your family
• Free annual eye tests and flu vaccinations