Engineering
Engineering

Quality Engineer

Manchester

Scope

Fantastic opportunity to join a global manufacturer of innovative market leading medical devices, an organisation that have been at the forefront of the coronavirus pandemic and continue to grow their teams at a rapid rate.

Responsibilities

Responsible for the continual improvement of processes and records related to validation, to drive improvements within the organisation and within the implementation of relevant and timely actions [including corrective and preventive], to ensure the continuing suitability, adequacy, and effectiveness of the company’s Quality System.

  • 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 quality systems, performs gap analysis, makes recommendations and initiates plans to improve existing systems.

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.
Oliver Allen Managed by Oliver Allen
highlights
North West
Permanent
Engineering
apply Posted - 11.02.2021

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