Quality Assurance Engineer

VQ Life Sciences
10 Jul 2019
13 Jul 2019
Contract Type
Full Time

VQ Life Sciences are recruiting for a Permanent QA Engineer based in the Northwest.

Job Purpose

  • Maintains the overall technical quality of product from design to commercialisation
  • Ensuring all Innovations R&D and Operations activities are conducted to the agreed GxP, regulatory standards and that safe working practices are current & adhered to at all times

Specific Responsibilities

Responsibilities of a QA Engineer include but are not limited to the following:

  • Participate in New Product Development (NPI) initiatives by providing quality engineering support to assigned projects
  • Oversee the Product Development Process and ensure defendable practices & scientific analyses are employed
  • Perform document review and approval of all quality impacting documentation (incl. engineering)
  • Participate in pilot plant development & technical transfer activities
  • Participate in product Risk Reviews during product development and post-launch activities as well as maintain product Risk Management files
  • Develop NPI Quality Plans
  • Lead process definition and improvement activities and training within the Innovations Operations and R&D functions
  • Provide QA oversight on validation and perform document review and approval of all validation documentation ie qualification/validation protocols, validation plan, supporting documentation eg URS, DQ
  • Improve awareness, communication, and training on quality procedures and initiatives to support corporate quality goals
  • Provide data analysis, trending of processes, products characteristics and other feedback on current product issues or developments to the business
  • Participate in continuous improvement activities in a cross-functional environment (eg Kaizen)
  • Maintain and comply with the requirements of ISO9001 and other applicable regulatory requirements
  • Identify areas for improvement of the QMS through active participation in internal audit program
  • Schedule and support audit activities including pre-audit planning, audit readiness and post-audit follow-up with lead auditor
  • Any other duties as assigned

KPI Areas/Measures of Performance

  • Internal & external audit performance ie Regulatory & Customer
  • Feedback from 1-2-1's & annual performance review

Experience & qualifications required

  • Strong organisational and multi-tasking skills
  • Ability to work effectively in a fast-paced environment & comfortable with continual change
  • Exposure to/experience with validation is highly advantageous
  • Excellent oral & written communication skills for effectively interfacing with all levels of management and departments within the internal/external business
  • Strong technical, analytical, and writing skills to identify and solve problems and document them appropriately
  • In-depth knowledge of GxP ie GMP (Good Manufacturing Practices), GDocP (Good Documentation Practices) and TPD (Tobacco Products Directive)
  • Excellent project management skills are strongly preferred
  • Good understanding of statistical methods, six sigma methodologies, design of experiments and lean
  • Ability to read technical drawings and experience in writing procedures to QMS requirements
  • Strong ability to manage and prioritise multiple projects while maintaining accuracy and meeting deadlines with the capability to balance short-term, urgent needs with long-term strategic initiatives
  • Systematic problem-solving skills in identifying, prioritising, communicating, and resolving quality issues
  • High attention to detail and processes
  • Goal oriented, interpersonal, self-motivated and team player
  • Knowledge of MS Office (Word, Excel) and other quality tools (Minitab, FMEA, SPC, etc.) and their application
  • Certification in Six Sigma green/black belt is an advantage


  • At least 5+ years of related experience in a manufacturing environment especially New product Development, Pilot Plant & Technology Transfer
  • Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820 is advantageous
  • Degree or higher in engineering or equivalent is desirable

If you have the relevant experience and interested in this Permanent QA Engineer position in the Northwest please apply.

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