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Quality Assurance Specialist

2 months ago


Hemel Hempstead, Hertfordshire, United Kingdom Merz Aesthetics UK and Ireland Full time
About the Role

As a Quality Assurance Associate at Merz Aesthetics UK and Ireland, you will play a crucial role in ensuring the quality management system operates efficiently and effectively. You will work closely with the QA Manager to prepare and deliver training in quality and compliance, manage document control and quality system data, and complete reports associated with quality management and compliance processes.

Key Responsibilities
  • Quality Documentation: Develop, implement, and maintain quality documentation, including procedures, work instructions, and records.
  • Quality Management Systems: Ensure the quality management system is compliant with regulatory requirements and industry standards, and that all processes are properly documented and controlled.
  • Risk Management: Identify, assess, and mitigate risks associated with quality management and compliance processes.
  • GDP Training and Education: Develop and deliver training programs to ensure employees understand quality and compliance requirements.
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.
  • Exceptional organisation skills, demonstrable ability to manage multiple workstreams concurrently.
  • Flexible, highly motivated, must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
  • Ability to work within a cross functional team, managing multiple stakeholders.
  • Effective interpersonal skills with the ability to communicate at all levels withing the organisation, concisely and clearly communicating complex and unfamiliar topics and ensuring understanding.
Competency Requirements
  • Teamworking
  • Passion for Results
  • Personal Accountability
  • Open and Transparent
  • Developing Self and Others
  • Innovation