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Quality Assurance Program Manager

Quality Assurance Program Manager

Job Description

Quality Assurance Program Manager

Location: Manchester, UK

How You’ll Add Value…

The Quality Assurance Program Manager will manage internal, customer and third-party audits related to FDA Quality System Regulation 21 CFR 820, ISO 13485, ISO 9001 and ISO 14971 with assistance from internal team.

What You’ll Do…

  • Manage key activities before, during and after audits to ensure rapid resolve of nonconformances.
  • Assist teams with preventive actions by collaborating with subject-matter-experts and other stakeholders
  • Manage project deliverables by working with global Quality Assurance Director and Quality Assurance Managers, such as compiling global audit results, global audit trend analysis and global continual improvement metrics
  • Works cross functionally with groups and functions such as supply chain, document control, engineering, quality, technical support and manufacturing to ensure training materials meets internal and industry requirements
  • Gather feedback from Quality Management System trainers, trainees, department managers and supervisors to ensure training is effective and adjust as needed
  • Maintain audit related educational support materials
  • Track and report on audit outcomes
  • Provide feedback to program participants and management via periodic report outs
  • Works under limited supervision on developing relatable training that requires a comprehensive knowledge of the discipline

What you will Bring…

  • Bachelor’s degree and 4+ years of experience of related experience in Life Sciences or Medical Devices
  • Experience with auditing and related training in a medical device manufacturing environment
  • Knowledge of a broad application of principles, theories, concepts, and techniques used in the applicable technical or business discipline and working knowledge of interrelated fields
  • Exercises judgment using generally defined practices and policies in selecting methods and techniques for arriving at solutions
  • MS Project or equivalent project management skills
  • Advanced data extraction, data analysis, auditing and reporting skills
  • Candidate must have excellent organizational skills, capable of maintaining project plans
  • Intermediate understanding of database management methods and techniques
  • Good interpersonal skills to function within teams
  • Good written skills to document and update documented processes and procedures

Working Conditions/ Schedule

  • Typical office environment with hybrid work options
  • May be asked to travel occasionally (anticipated to be around 10%)

Job Specifications

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