Plant Floor Quality Analyst: CAPA, Audits&Compliance, Kempton Park

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

About The Role We are looking for a

Quality Analyst

to join our team and play a key role in ensuring product quality, regulatory compliance, and continuous improvement across our operations.

This is a

hands-on, operational role , with strong presence on the plant floor. You will lead investigations, drive root cause analysis, and implement corrective actions, ensuring that all processes comply with applicable standards including ISO 13485, FDA 21 CFR Part 820/211, EU GMP and ISO 11137.

Key Responsibilities

Lead and manage nonconformance investigations, including customer-facing issues and communication

Execute product and report release for processing runs involving deviations

Drive root cause analysis and ensure effective CAPA implementation

Support and manage internal audit remediation activities

Develop and maintain quality system policies, procedures, and documentation

Analyze quality data using statistical techniques and recommend improvements

Monitor, track, and report on quality performance metrics

Provide guidance and training to colleagues on quality principles and continuous improvement

Collaborate cross-functionally to embed quality in daily operations

Lead and support key QMS programs, including

CAPA

Complaints handling

Calibration and maintenance

Supplier quality

Document and change control

Validation and risk management

Ensure compliance with customer specifications and regulatory requirements, including audits, dosimetry, validations, and reporting

Minimum Requirements

Degree or diploma in Science, Life Sciences, or relevant technical field

3-5 years’ experience in a regulated environment

Strong knowledge of quality systems, GMP, and ISO standards

Experience with quality data analysis and reporting

Proficiency in Microsoft Office (Excel, Word, PowerPoint)

Valid driver’s license and own transport

Strong analytical and problem-solving skills

Excellent written and verbal communication skills

Ability to work both independently and within cross-functional teams

Comfortable working in a fast‑paced, highly regulated environment

Preferred Qualifications

Experience in medical device or pharmaceutical industry

Working knowledge of ISO 13485 and GMP environments

Exposure to sterilisation processes or gamma technology

Training in Total Quality Management (TQM) or similar

Key Competencies

Strong ownership and accountability

Attention to detail and compliance mindset

Data‑driven decision making

Continuous improvement focus

Ability to influence and collaborate across teams

STERIS strives to be an Equal Opportunity Employer.

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