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Quality Assurance Manager

Vivid Resourcing Ltd
Reino Unido

Registada há 5 anos no SAPO Emprego 136457 ofertas anunciadas nos últimos 6 meses

Detalhe da Função

The Key Responsibilities

  • Supports Commercial and R&D initiatives around site specific capabilities and technologies.
  • Oversees all QA/QC/QE activities in Windsor
  • In conjunction with the VP Global Quality, leads and facilitates the standardization of all quality processes and procedures in Windsor with other Healthcare sites
  • Implements and maintains ISO 9001/ISO13485/GMP/FDA/Medical device standards and regulations in R&D, QA, and Manufacturing areas
  • Champions a dynamic and proactive quality culture with a "hands-on approach" in guiding and coaching teams
  • Assures that the Windsor site has robust and documented internal audit processes and procedures to identify quality improvement opportunities
  • Manages and standardizes change control to assure quality system effectiveness
  • Reviews and approves customer quality agreements and final customer specifications
  • Sets and maintains standards of performance and reporting of Quality KPI'S for Windsor
  • Leads, develops, and standardizes all equipment, process, and product validations
  • Ensures that all key raw material specifications are aligned to customer specifications, including measured performance indicators of all key suppliers
  • Tracks and trends internal and external customer complaints to identify improvement opportunities, including the management of a robust SCAR and CAPA program
  • Champions waste reduction and quality improvement initiatives using lean and six sigma tools to drive a culture of continuous improvement
  • The QA Manager shall act as the key contact for all matters concerning Quality for the Windsor site
  • Facilitates reporting and actions on internal and external customer complaints, including product recalls and adverse event reporting
  • Ensures effective and collaborative communication within the team
  • Supports the development of new products using standardized PLM and Design Control processes and procedures
  • Ensures a safe and clean working environment

Essential Skills And Experience

  • Strong working knowledge of standards and regulations related to ISO 9001, ISO 13485, ISO/TS 16949, ISO 14971, 21CFR:820, 21CFR:210/211 and FDA requirements for combination products standards in order to maintain accreditation.
  • Demonstrate a good understanding of the challenges associated with working in a regulated product area.
  • 3 Years minimum experience in a site Quality Assurance Management role in a Medical Device/Component Manufacturing Environment
  • Preference given to certified Quality Assurance Managers and Senior Quality Engineers, with prior internal/external regulatory audit experience
  • BS Degree in the Sciences
  • PC literate and use of Microsoft Office suites with excellent communication skills, both verbal and written.
  • Lean/Six Sigma experience certification preferred
  • Good analytical skills with the ability to utilise it to deliver improved performance
  • Problem solving and decision making using root cause analysis tools with on-going statistical trend analyses in detecting shifts in quality performance
  • Continuous improvement and quality excellence
  • Medical device and Combination Product knowledge of FDA and GMP experience
  • Project management of quality improvement and waste reduction initiatives
  • Strategic quality plan development and execution
  • Self-motivated with a high sense of "urgency" and self-initiative
  • Demonstrates the ability to build and lead cross-functional teams for the site
  • Attention to detail

Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.

Employment Type: Permanent
Work Hours: Not Specified
Salary Currency: British Pound . GBP
Salary Period: Annual
Salary (Additional):

Pesquise também por: Quality Assurance Manager



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