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Quality Assurance Supervisor

3 months ago


Basingstoke, Hampshire, United Kingdom Thermo Fisher Scientific Full time

Position Title: Quality Assurance Supervisor

As a pivotal member of our team, you will:

  • Oversee and guide a team of Quality Assurance professionals.
  • Deliver leadership in managing investigations, deviations, change controls, validation processes, standard operating procedures (SOPs), and in-process quality controls.
  • Foster collaborative partnerships between Operations and Quality to enhance the overall customer experience.
  • Support Operations in diagnosing and resolving quality and process-related challenges.
  • Collaborate with Operations, Research & Development, Procurement, and Engineering to elevate quality standards and minimize costs.
  • Concentrate on enhancing efficiency and compliance within the quality management framework.
  • Work alongside Operations to set up controls and inspection points for nonconforming materials, components, assemblies, and finished products.
  • Act as the Quality Representative for all corrective and preventive actions related to quality.
  • Ensure adherence to company policies, as well as national and international regulations and safety standards.
  • Examine trends, perform root cause analyses, and implement corrective measures for processes and products.

Essential Qualifications:

  • Bachelor's degree in a scientific discipline or a related field.
  • Demonstrated experience in a regulated sector, preferably in quality assurance within the medical device or pharmaceutical industries.
  • Experience in managing and nurturing a team within a quality-focused environment.
  • Strong foundation in process control and statistical methodologies.
  • Familiarity with medical device regulations, current Good Manufacturing Practices (cGMP), European Union regulations, or ISO 13485 standards.
  • Exceptional interpersonal communication skills, both verbal and written.
  • Self-motivated with the capability to achieve results from broad concepts and guidance.
  • Ability to manage multiple priorities in a global, multi-site organization.
  • Effective collaboration within cross-functional teams.
  • Proficiency in quality management tools such as Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), Design of Experiments (DOE), and Six Sigma/Process Improvement methodologies.
  • Strong digital proficiency, including experience with SAP, Microsoft Word, Excel, and PowerPoint.
  • Expertise in qualification and validation processes (including sterilization, cleaning, and software validation).

Key Competencies:

  • Outstanding interpersonal abilities.
  • Strong leadership and influence skills.
  • Capability to work autonomously as well as collaboratively.
  • Robust quality assurance background and decision-making capabilities.
  • Aptitude for addressing complex issues while aligning with regulatory requirements.
  • Commitment to continuous improvement initiatives.