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QA Process Development Engineer

Date: 04-Apr-2021

Location: Oldham, GB

Company: Mölnlycke Health Care


Are you passionate about making life better for patients worldwide?


If the answer is yes, you think just like us. We are a world-leading medical solutions company, designing and supplying medical solutions to enhance performance in healthcare – from the hospital to the home. We’re looking for a QA Process Development Engineer to help improve outcomes for healthcare professionals and their patients.


The role:


The department is responsible for responding efficiently to quality incidents, coordinate validation activities and proactively identifying opportunities for continuous improvement of the Quality systems and processes across the Oldham site. The areas will include Quality Systems, Production processes, raw materials and finished product testing. A key focus of the role will be root cause investigations into production issues utilising root cause analysis to deliver timely completions, complaint investigations and validation protocol and report writing. You will be working closely with a QA Process Technician and there is an expectation to positively impact their development and career progression. This key position will work across our Wound Care and Textiles business units.


Key Responsibilities:


  • Coordinate IQ, OQ, PQ validation activities, updating VMP and completing revalidation assessments
  • Lead on the business unit complaints handling whilst assisting in other business units
  • Manage the internal system audits and lead on external supplier audits
  • Drive CAPA activities including root cause analysis and solution implementation
  • Oversee Quality Impact Assessment and other Risk Assessments
  • Maintain visibility and presence in the active production areas
  • Assist with product release processes
  • Deputise in place of the Quality Managers absence


Qualifications & Experience:


  • Excellent knowledge of current validation protocols including IQ, OQ, PQ methodology - Essential
  • Previous experience in a similar regulated quality environment - Essential
  • Knowledge of requirements for ISO and similar standards
  • Demonstrable use of route cause analysis tools
  • Prior use of CAPA and complaints handling systems
  • Knowledge of continuous improvement techniques
  • Detail orientated and focused on getting things right first time


About Mölnlycke


Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home.