QA Manager

Location: Kent  |  Kent  |  England
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHQAM
Salary: £38000 - £50000
Job Status: Permanent / Full Time

Job title

Quality Manager

 

 

Description of Role

Responsible for ensuring that all products and service meet the established standards of quality including reliability, usability and performance. To Ensure that my clients remains complaint with ISO 9001- 13485 and Medical Device Regulations. 

Key Skills

  • Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods
  • Develop training to build quality awareness
  • Be focused with attention to details, follow instructions, be attached to quality systems and regulations and keep working safe
  • Root cause analysis and implementation of corrective action for process related concerns
  • Commercial awareness
  • Capable of working well under pressure
  • Team-working
  • Computer skills, proficient with Microsoft Office Analytical skills
  • Dealing with Complexity,
  • Effective written and verbal communication skills
  • Understanding technical information
  • Being highly professional and proficient
  • Knowledge of automated Quality Management Systems (I. e Master Control System)

 

Qualifications

  • Must have 5-10  years’ experience in Quality Engineering/Manufacture
  • Must have worked minimum 5 years on Medical Products
  • Must be trained in ISO 9001 & 13485
  • Must high level education, HNC/HND or Degree in Engineering Discipline  

Core duties (With Support From Praxair)

  • Compliance with Medical Device Regulations
  • Management of CE marking files
  • Management of FDA 510k / PMA files
  • Management of NRTL (UL/MET etc) files and ongoing compliance
  • RoHS/WEEE/REACH
  • Regulatory testing submissions (60601/62304/62366)
  • Device vigilance and competent authority reporting (MHRA)
  • Risk management (new and ongoing) to ISO 14971
  • Technical file/DMR management / Validation
  • Monitor and review of latest standards and regulations

 

 Key QA Activities

  • Audits internal/External
  • Control Device History Files
  • Risk Assessments Internal auditing
  • Document and record control
  • Identification and traceability control
  • Calibration control
  • Customer complaints
  • Non-conforming product
  • Corrective and Preventive Actions (CAPA)
  • Management of Change process, re-validation activities
  • QA final acceptance of product release, ensure all products meet product specification and that all associated documentation is maintained
  • Continuous improvement including  receiving inspection process and procedures
  • Product Registration support
  • Ensuring good quality work is maintained, develop training and conduct GMP training
  • Establishing, implementing and maintaining the quality management system.
  • Ensure that products and processes comply with the relevant requirements of the quality management system
  • Analyse failure Root Cause Investigations, complaints, non-conformances and manufacturing deviations
  • Responsible for planning, organising and managing the overall activities of receiving / outgoing quality products
  •  

Key Health and Safety Activities

  • Implement H&S policies
  • Workplace inspection/Hazard identification
  • Risk assess and reporting
  • Ensure equipment is functional
  • Maintain records
  • Ensure Organisation is compliant
  • Respond to and investigate accidents and emergencies
  • Conduct trainings with staff
  • Monitor Compliance with legislative and regulatory requirements
  • First Aid Training/Records
  • Fire Training/Drills/Records