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Quality Engineer

Premier Group Recruitment
Job LocationManchester
EducationNot Mentioned
Salary£28,000 - £45,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Product Quality EngineerPermanentManchesterSUMMARYResponsible for supporting NCEs, product transfers, complaint investigation, QSIand Corrective and Preventative Actions to ensure the maintenance of product quality. Achieved through the application of root cause analysis, statistical techniques and risk management to ensure the continuing suitability, adequacy and effectiveness of The Clients Quality System.ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Supports Product Quality Engineering through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness, through Material Review Board.
  • Ensures current and applicable standards, regulations and requirements are appliedISO 13485, ISO 14971, 21 CFR Part 820, IVDR.
  • Creates documentation associated with product quality engineering activities including, test plans, and the update of quality system and department procedures.
  • Defines technical investigations plans, reports and related procedures which ensure statistical validity, adequacy and compliance to regulatory and corporate requirements.
  • Attends regular communication meetings with cross-functional teams to identify the root cause of problems and creates remedial plans for short-term and long-term resolutions.
  • Applies risk management to investigation and product activities and facilitates risk assessments using tools such as Process/Design Failure Mode and Effects Analysis
  • Generates, reviews and approves applicable lifecycle documents, including requirement specifications, Standard Operating Procedures, work instructions, test plans, forms, investigations, CAPAs, and any pertinent test data. Performs investigations and troubleshoots problems for continual improvement.
  • Supports activities associated with aspects of the Quality Management System including:
    • Participation in compliance meetings
  • Performs diagnostic assay and/or amplified assay consistently with acceptable results, were required.
  • Performs basic troubleshooting to resolve unexpected results when performing Diagnostic and /or amplified assays.
    • EDUCATION AND EXPERIENCE
  • BS or equivalent in scientific discipline, engineering, or related discipline
  • Minimum of 6 years’ experience in the in vitro diagnostics, medical device or pharmaceutical industries.
  • Must be proficient in the knowledge of applicable standards, regulations and requirements
  • Must have advanced knowledge of QA, Manufacturing, Method Validation, Change Control, and Design Control processes.
  • Proficient in concepts of statistics, sampling plans and statistical analysis.
  • Ability to independently plan, execute, and/or problem solve moderate to complex situations.
  • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc. effectively.
    • If this is something that you would be interested in then please send you would be interested in then please send your most up to date CV to

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