Engineering
Engineering

Quality Engineer

Manchester

Scope

Fantastic opportunity to join a globally recognised manufacturer of medical devices achieving YoY growth across EMEA and UK. Their teams have been heavily expanding due to organic growth, company acquisitions, and innovation across their portfolio of Surgical and Diagnostics products. The successful candidate will join a team that promotes a culture of togetherness and will be provided with the opportunity to develop internally as exciting projects in the pipeline will fall under this persons responsibilities. Equipment, Facility, Process Validation in the medical devices or pharmaceuticals industry is essential to hit the ground running and have a large impact.

Responsibilities

  • Mentors and advises the organization on what is required in validation master plans, and related protocols and reports
  • Develops, reviews, and approves master validation plans, strategies, protocols, and reports
  • Establishes and evaluates adequacy of validation methods for new or modified processes, equipment or facility changes
  • Reviews and approves validation protocols and reports in conjunction with the supporting data and documentation for adequacy and completeness
  • Evaluates adequacy of specifications for new or modified designs.
  • Develops and reviews risk assessments and risk strategies. Able to effectively use risk assessment tools like FMEAs and FTAs
  • Reviews and approves risk analysis for adequacy; able to evaluate changes to a design and associated risk documents.
  • Manages, reviews, and approves Change Control packages for all types of changes (e.g. documents, equipment, facilities, instrumentation, process, cleaning)
  • Assures compliance with regulations and internal SOPs for validation efforts performed by internal/external personnel

About You

  • BS or equivalent in scientific discipline, engineering, or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 6 years’ experience in the in vitro diagnostics, medical device or pharmaceutical industries.
  • Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements
  • Must have advanced knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes
  • Proficient in a variety of validations and data evaluation methods
  • Proficient in spreadsheets and word processor applications
  • Proficient in concepts of statistics, sampling plans and statistical analysis
  • Proficient in analytical methods, equipment, process, software, cleaning and/or facility/utility validations
  • Proficient in a variety of validation methods & evaluation criteria
  • Proficient in statistical principals of DOE, ANOVA, SPC, Cpk etc.
  • Proficient in understanding of engineering drawings and symbols
  • 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
  • Must demonstrate initiative, balanced assertiveness working as a team player
  • Solid oral and written communication skills
  • Ability to manage multiple projects
If you are interested in the above role then please apply or get in touch to discuss further.
Ed Curl Managed by Ed Curl
highlights
North West
Permanent
Engineering
apply Posted - 24.03.2021

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Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.