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Quality Assurance Manager

2 months ago

Leatherhead, United Kingdom Park Street People Full time

Job Title: Quality Assurance Manager

About the Role:

Park Street People is seeking a highly skilled Quality Assurance Manager to join their team on a full-time, permanent basis. As a Quality Assurance Manager, you will be responsible for leading a talented team of engineers, working closely with cross-functional departments, and overseeing all quality assurance processes, from product design to regulatory compliance.

Key Responsibilities:

  • Lead and mentor a team of Quality Engineers: Foster a culture of continuous improvement, ensuring that the team is equipped to meet the highest standards of quality.
  • Oversee quality systems: Ensure compliance with medical device regulations, including ISO 13485 and FDA regulations.
  • Collaborate with cross-functional teams: Enhance product design, development, and manufacturing processes to ensure that products meet the highest standards of quality and safety.
  • Drive root cause analysis, corrective actions, and risk management strategies: Identify and mitigate risks, ensuring that products are safe and effective.
  • Ensure the execution of validation processes (IQ, OQ, PQ) and documentation management: Ensure that all validation processes are completed to the highest standards, and that documentation is accurate and up-to-date.

Requirements:

  • Proven experience in quality engineering: Ideally within the medical devices or healthcare sector.
  • In-depth knowledge of regulatory standards: Familiarity with ISO 13485 and FDA regulations.
  • Strong leadership skills: Proven track record of mentoring and developing high-performing teams.
  • Excellent problem-solving abilities: Proactive approach to quality management.
  • Strong communication and collaboration skills: Ability to work effectively with cross-functional teams.

About Park Street People:

Park Street People is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed, or sexual orientation and comply with all relevant UK legislation.