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Quality Executive

3 months ago

Cardiff, Cardiff, United Kingdom Eakin Healthcare Group Full time

ABOUT THE ROLE

Reporting to the Quality Manager, the Quality Executive will be responsible for ensuring Quality Assurance Compliance to the UK based businesses, Respond Healthcare, Pelican Healthcare & Pelican Feminine Healthcare.

The Quality Executive role is key to the success of the UK businesses Regulatory and Quality strategy, ensuring the development of Quality assurance strategy reporting on all aspects of the Quality Management System (QMS).


KEY ACTIVITIES

  • Act as supervisory lead for one member of QA team
  • Participate in New Product Development (NPD) teams as assigned
  • Represent the UK QA team on matters of quality assurance compliance, providing guidance ensuring adherence
  • Represent the UK Businesses at all external agency & customer inspections and audits
  • In conjunction with the Quality Manager & Regulatory Affairs Manager execute aspects for any Field Safety Corrective Actions (FSCA) in a timely, thorough, and transparent manner
  • Review requested QMS documentation creations, revisions & obsoletion
  • Deliver Internal quality assurance training for departments, including Quality Induction
  • As a member of the UK QA team, develop and implement a system for imbedding QARA culture through the UK Businesses
  • Responsible for ensuring the UK businesses quality management system reflects practice and is kept up to date in line with requirements
  • Upon receipt review and release all Ethylene Oxide (EtO) products
  • Support both the Internal and Supplier audit schedule, conducting inspections when assigned
  • Ensure QA budget is worked within as approved and monitored
  • In conjunction with other departments, ensure all reported Customer Complaints are acknowledged, investigated, and reported on
  • Coordinate and own Corrective and Preventative Actions, Customer Complaints, Non-Conformances/concessions, Calibration Register, Validation Master Plans, environmental monitoring activities
  • Log, measure and analyse QMS and product Key Performance Indicators, demonstrating QMS compliance
  • Provide reports on agreed frequency on all matters associated with quality compliance to the Quality Manager

Other

  • To adhere to the company's Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
  • To be responsible for your own health and safety and that of your colleagues, in accordance with the company's' Health and Safety policy
  • To adhere to the company's Quality policy and Environmental policy
  • To undertake other duties as may be reasonably required

KEY SKILLS

Essential

  • Experience in a Quality role, with Compliance experience in a regulated industry and working to a quality standard
  • Strong communication skills, both verbal and written
  • Proactive and able to work autonomously
  • Competent in the use of Microsoft office packages
  • Full UK driving license

Desirable

  • Experience within the Medical Device Industry, working to ISO standards and FDA CFR in a continuous environment
  • Educated to A Level
  • Methodical with analytical and problemsolving skills

KEY WORKING RELATIONSHIPS

Internal

  • Quality
  • Manufacturing
  • Supply Chain
  • Procurement

External

  • Project Team Members
  • Suppliers and Customers
  • Notified Bodies

ADDITIONAL INFORMATION

  • Occasional UK travel

COMPETENCIES

Problem solving - Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.

Supporting Others - Enjoys supporting other people and is prone to getting involved and trying to help them when they have problems. Is comfortable to contribute to joint endeavours and enjoys team work. Is willing to let other people depend on them.

Analytical - Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail

Following Directions - Is motivated to accept and comply with standards and instructions and has a strong conscience about delivering what is promised or expected. Doesn't like letting people down and works productively in cooperation with, and support of others.

Information Gathering - Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.

Quality Orientation - Is precise, pays attention to details, checks things and ties up 'loose ends'. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.

Oral Communication - Talks readily and confidently to people, expressing themselves with obvious ease. Speak out and makes themselv