Quality Engineer / Quality Auditor

Halma plc; Pennsylvania; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Keeler USA, a part of Halma, is seeking an experienced Quality Assurance professional to lead QA activities in its Malvern, PA operations. The role focuses on maintaining ISO 13485:2016 compliance, managing CAPAs, and driving continuous improvement across manufacturing processes.

You will collaborate with Global QA to ensure robust QMS implementation and support audits of internal and supplier processes while guiding incident and complaint investigations and continual quality enhancements.

Qualifications

• Experience in Quality Assurance within a manufacturing environment.
• Minimum 3 years of relevant experience in medical devices, pharmaceuticals, or another highly regulated industry.
• Lead Auditor training and certification.
• Solid knowledge of ISO 13485:2016 and USA regulations.
• Experience with CAPAs (Corrective and Preventive Actions).
• Risk Management to ISO 14971.

Responsibilities

• Oversee the QA system within Keeler USA Operations, ensuring compliant output across processes.
• Develop and drive quality/operations improvement projects.
• Support pharmaceutical compliance and continuous improvement initiatives.
• Conduct gap analyses and ensure readiness for regulatory audits.

Skills

Quality Assurance

Regulatory knowledge

Auditing

CAPA management

Risk management

Education

Bachelor's degree in a relevant field

Tools

QMS software

eQMS

Job description

Work with a leading company in the industry that creates life-changing products and solutions

A recognised industry expert, Keeler focuses on providing revolutionary eye care solutions, manufacturing all its instruments with optical precision, high quality illumination and ergonomic design.

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 cause
• Manage, 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 audits

CUSTOMER 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.
• Customer liaison and responses, as needed.

About You

• Experience and working knowledge of Quality Assurance
• Minimum 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 certified
• Ability to confidently provide QA support across the global business
• Working knowledge of ISO 13485:2016 and local USA medical device manufacturing and pharmaceutical distribution regulations.
• Experience with Risk Management to ISO 14971

Location 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.

Join 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.

Our purpose is to play an enduring role in helping our customers bring an end to preventable vision loss.

Together

We respect the diversity of our global team, embracing our combined knowledge to help us improve together

Improve

We lean into our passion and determination to continuously grow the business whilst challenging ourselves to be better

Action

We work with respect and integrity, taking accountability to pursue the right course of action, not the easiest

Heart

We care deeply about our colleagues, customers, partners and patients. We strive for excellence every day but we do it with a smile and a sense of fun and camaraderie