JOB PROFILE: QA Engineer

INCUMBENT’S NAME
JOB TITLE / Quality Assurance Engineer
BUSINESS UNIT / Quality Assurance
LOCATION / Worthing
REPORTS TO / Andrew Wells - QA Manager
OBJECTIVES
PURPOSE OF JOB /
  • To provide support for new product introduction.
  • To participate in continuous process improvement and defect reduction initiatives.
  • To conduct CAPA investigations.
  • To act as QA representative for product and process change requests and validation protocols.
  • To perform product release activities

KEY ACTIVITIES
RESPONSIBILITIES /
  • Assisting the QA Manager in the development, implementation and continual review of quality controls in QA and Production departments including receiving inspection processes and in-line manufacturing processes.
  • Supporting new product and process development projects
  • Supporting the implementation of continuous improvement initiatives
  • Supplier evaluation/approval/performance monitoring
  • Be the point of contact in supplier audits, as well as conducting internal and external audits
  • Non-conformity investigation, reporting and trending
  • CAPA investigation, reporting and trending
  • Change control review
  • Participation in process and equipment validation exercises
  • Product release
  • Tracking/trending results from Goods Receiving Inspection, In-process and Batch Control activities
  • Management of ad hoc investigatory projects
  • Deputising for QA Manager
  • Be an advocate for promoting quality and GMP across the organisation
Act in line with our Company Values:
  • Ambition: We have the drive to continuously improve
  • Integrity: We are accountable for what we do acting ethically and in the best interests of our customers, patients and stakeholders
  • Openness: – We positively consider new ideas and challenges
  • Respect: - We support each other and our customers to succeed

KEY PERFORMANCE INDICATORS / Based in annual performance objectives, or specify otherwise
KEY RELATIONSHIPS / Internal:
  • Quality Assurance Department
  • Production Department
  • Regulatory Affairs Department
  • R&D Department
External:
  • Contract Test Laboratories
  • Suppliers (general)

CANDIDATE PROFILE:

QUALIFICATIONS/ TRAINING /
  • Degree, equivalent qualification or equivalent experience in a science, clinical or engineering background

EXPERIENCE
(E.g. health care industry, multinational company, what level/types of roles etc.) /
  • 2-5 years’ experience in a Quality Engineering role
  • Experience with Quality System concepts, practices and procedures (e.g. ISO:13485, CFR820)

COMPETENCIES
(knowledge, skills and attributes – including language requirements, ability to travel, etc) /
  • Familiar with using databases and business management systems (ERP).
  • Competent in IT practices and use of Microsoft applications.
  • Possess the ability to investigate and solve complex issues and define root cause using good analytical skills.
  • Strong communicator with excellent oral and written presentation skills.
  • Possess the ability to work alone and as part of multi-disciplinary teams.