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Medical Device Quality Manager

2 months ago

Hemel Hempstead, Hertfordshire, United Kingdom Merz Aesthetics UK and Ireland Full time
Job Description

Role Purpose

The Quality Assurance Associate supports the Quality Assurance Manager in ensuring the quality management system operates efficiently and effectively. Key aspects include preparing and delivering training in quality and compliance, document control and management, completion of reports associated with quality management and compliance processes, collection and analysis of quality system data.

Main Responsibilities

  • Quality Documentation
  • Quality Management Systems
  • Risk Management
  • GDP Training and Education

Key Working Relationships

  • Quality Assurance Manager, line manager
  • Financial colleagues and Customer Services to ensure activities are aligned with process and compliant
  • Medical affairs colleagues (Regulatory Affairs, Scientific Advisors, Medical Scientific Liaison, Medical Information Scientists) as well as the License Holder and Finance Director
  • Commercial colleagues in marketing and sales to ensure activities are fair, balanced and compliant

Qualifications, Experience & Knowledge Requirements

Mandatory:

  • A minimum of a BS preferably in Chemistry or Life Sciences.
  • Minimum of 2 years of experience in medical devices or pharma industry in a quality assurance role, or other relevant experience regulated industry.
  • Strong written and verbal communication skills, analytical and data analysis, problem solving, and conflict resolutions skills.
  • Flexible, highly motivated, must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.

Competency Requirements

  • Teamworking
  • Passion for Results
  • Personal Accountability
  • Open and Transparent
  • Developing Self and Others
  • Innovation

About Us

Merz Aesthetics UK and Ireland is a leading provider of innovative aesthetic solutions. Our commitment to advancing medicine in aesthetics drives our mission to help people look better, feel better, and live better. We offer a range of treatment options that allow Healthcare Professionals to use our technologies to treat a broad range of patients' concerns.