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.
Product evaluation & testing.
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.
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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.
