Quality Engineer / Quality Auditor

Halma plc; Malvern (Chester County); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Keeler, part of Halma, seeks a QA professional to lead quality assurance activities across US operations in Malvern, PA. The role focuses on ensuring compliant output, driving continuous improvement, and supporting ISO 13485 compliance and customer audits.

Responsibilities include CAPA management, change control, risk assessment, and monthly KPI reporting. A strong QA background in regulated manufacturing is required, with hybrid work and occasional travel.

Qualifications

• Experience and working knowledge of Quality Assurance in manufacturing/regulated environments.
• Proficient in CAPAs, change control and audit processes.
• Familiarity with ISO 13485:2016 and US medical device regulations.

Responsibilities

• Lead QA activities within Keeler USA operations to ensure compliant output.
• Drive QA projects and continuous improvement across processes.
• Prepare and deliver KPI reporting and risk assessments.
• Support QMS induction and training for new starters.

Skills

Quality Assurance

CAPAs

Audits

Root cause analysis (5 Whys, Fishbone)

Risk Management

Change control

ISO 13485 knowledge

QMS / eQMS

Tools

QMS software

FMEA

Job description

As a global market leader in the world of eyecare, Keeler’s dynamic business creates an exciting opportunity for career development.We are a vibrant, future-facing organisation, with over a century of industry expertise. The highly-trusted Keeler brand supports our consistent revenue growth. We actively foster a diverse, inclusive work environment and continuously seek to drive sustainability across our organisation.Keeler is a part of Halma, a global group of life-saving technology companies focused on growing a safer, cleaner, healthier future for everyone, every day. Employing over 7,000 people in more than 20 countries, Halma has major operations in the UK, mainland Europe, the USA and Asia Pacific. Halma is listed on the London Stock Exchange (LON: HLMA) and is a constituent of the FTSE 100 index.You will be responsible and accountable for the following:QUALITY ASSURANCE:Manage Quality Assurance within Operations, ensuring consistent compliant output in operations, including incoming goods inspection, final build inspection etc.Drive and assist quality / operation-based projects.Assist with pharmaceutical compliance & quality upkeep / projects / continuous improvement.Own, monitor and improve the Quality Assurance (QA) System within Keeler USA Operations. Reduce waste and increase efficiency of the QA System.Review and improve Operations’ quality procedures, standards, and specifications.Champion the training and use of relevant quality tools across Keeler.Represent USA Quality Team at Design Change meetings.QMS:Support the adoption and ongoing management of the QMS.Development of the QMS procedures and associated Work Instructions and documentation.Compliance to ISO 13485:2016 and local Pennsylvania / United States regulations and other global requirements.Usage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root causeManage, Maintain and Implement CAPAs (Corrective and Preventative Actions).Continuously improving processes to promote more agile workflows.Conduct gap analysis for standards and regulations, when required.Provide QMS Induction training for new starters.Preparation and delivery of monthly KPI presentations/ Metrics reporting.Contribute to product Risk Assessment.Providing support and guidance in the development and implementation of quality management systems.Support the Global Quality Manager with the merge into global eQMS.AUDITS:Conduct internal and supplier audits, ideally as an ISO 13485:2016 Internal Auditor.Co-host Notified Body, regulatory authority and customer auditsCUSTOMER COMPLAINTS:Investigation and documentation of safety-related complaints (CAPA & Incident Reports).Overseeing complaint analysis and reporting complaint trends.Assist with incident reporting to regulatory authorities.Product evaluation & testing.Customer liaison and responses, as needed.About YouExperience and working knowledge of Quality AssuranceMinimum 3 years of relevant experience within manufacturing environment, in medical devices, pharmaceuticals, or another highly regulated industry.Experience in change control processes.Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event.Sound knowledge of CAPAs (Corrective and Preventative Actions)Lead Auditor trained and certifiedAbility to confidently provide QA support across the global businessWorking knowledge of ISO 13485:2016 and local USA medical device manufacturing and pharmaceutical distribution regulations.Experience with Risk Management to ISO 14971Location of this role is based in Malvern, PA, with working from home/travelling hybrid model. Business hours are 8:30 a.m. – 5 p.m., Monday – Friday.#Keeler #LI-KK3Join us in creating and delivering life-changing products and solutions that impact millions of people around the world, helping our customers bring an end to preventable vision loss.