Quality Analyst (Kempton park, GP, ZA, 1600)

<p>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.</p><div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="word-wrap:break-word"><H2 style="margin:0.0px"></H2> </div><div><div> <h2><strong>About the Role</strong></h2> <p>We are looking for a <strong>Quality Analyst</strong> to join our team and play a key role in ensuring product quality, regulatory compliance, and continuous improvement across our operations.</p> <p>This is a <strong>hands-on, operational role</strong>, 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 <strong>ISO 13485, FDA 21 CFR Part 820/211, EU GMP and ISO 11137</strong>.</p> </div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="word-wrap:break-word"><H2 style="margin:0.0px"></H2> </div><div><div> <h2><strong>Key Responsibilities</strong></h2> <ul> <li>Lead and manage <strong>nonconformance investigations</strong>, including customer-facing issues and communication</li> <li>Execute <strong>product and report release</strong> for processing runs involving deviations</li> <li>Drive <strong>root cause analysis</strong> and ensure effective <strong>CAPA implementation</strong></li> <li>Support and manage <strong>internal audit remediation activities</strong></li> <li>Develop and maintain <strong>quality system policies, procedures, and documentation</strong></li> <li>Analyze quality data using statistical techniques and recommend improvements</li> <li>Monitor, track, and report on <strong>quality performance metrics</strong></li> <li>Provide guidance and training to colleagues on <strong>quality principles and continuous improvement</strong></li> <li>Collaborate cross-functionally to embed quality in daily operations</li> <li>Lead and support key <strong>QMS programs</strong>, including: <ul> <li>CAPA</li> <li>Complaints handling</li> <li>Calibration and maintenance</li> <li>Supplier quality</li> <li>Document and change control</li> <li>Validation and risk management</li> </ul> </li> <li>Ensure compliance with <strong>customer specifications and regulatory requirements</strong>, including audits, dosimetry, validations, and reporting</li> </ul> </div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="word-wrap:break-word"><H2 style="margin:0.0px"></H2> </div><div><div> <h2><strong>Minimum Requirements</strong></h2> <ul> <li>Degree or diploma in <strong>Science, Life Sciences, or relevant technical field</strong></li> <li><strong>3–5 years’ experience</strong> in a regulated environment</li> <li>Strong knowledge of <strong>quality systems, GMP, and ISO standards</strong></li> <li>Experience with <strong>quality data analysis and reporting</strong></li> <li>Proficiency in <strong>Microsoft Office (Excel, Word, PowerPoint)</strong></li> <li><strong>Valid driver’s license and own transport</strong></li> <li>Strong analytical and problem-solving skills</li> <li>Excellent written and verbal communication skills</li> <li>Ability to work both independently and within cross-functional teams</li> <li>Comfortable working in a <strong>fast-paced, highly regulated environment</strong></li> </ul> <h2> </h2> <h2><strong>Preferred Qualifications</strong></h2> <ul> <li>Experience in <strong>medical device or pharmaceutical industry</strong></li> <li>Working knowledge of <strong>ISO 13485 and GMP</strong> environments</li> <li>Exposure to <strong>sterilisation processes or gamma technology</strong></li> <li>Training in <strong>Total Quality Management (TQM)</strong> or similar</li> </ul> </div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="word-wrap:break-word"><H2 style="margin:0.0px"></H2> </div><div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="word-wrap:break-word"><H2 style="margin:0.0px"></H2> </div><div><div> <h2><strong>Key Competencies</strong></h2> <ul> <li>Strong ownership and accountability</li> <li>Attention to detail and compliance mindset</li> <li>Data-driven decision making</li> <li>Continuous improvement focus</li> <li>Ability to influence and collaborate across teams</li> </ul> </div></div></div></div><p> </p> <p>STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit <a href="https://www.steris.com">www.steris.com</a>.</p> <p>STERIS strives to be an Equal Opportunity Employer.  </p>