Supplier Quality Engineer

Location: Cardiff

Contract Type: Permanent Full Time

Closing Date: 07 October 2022

Salary: Competitive

Supplier Quality Engineer

ABOUT THE ROLE

Reporting to the Quality Manager, the SQE will work closely with the Supplier base of the Eakin Healthcare Companies, striving for excellence in supplier quality performance and continuous improvement. SQE will ensure that Supplier Audits are conducted in line with agreed schedule, and Supplier Corrective Action Requests (SCAR) are raised and closed out accordingly and in line with QMS procedural requirements. This role can be based in Cardiff, Coleraine or Comber.

 

KEY ACTIVITIES

  • Create, implement and manage a risk-based Supplier Audit Schedule.
  • Schedule, organise, plan, conduct and report on all assigned Supplier Audits as per schedule, ensuring record keeping of all audit activities. This will include auditing both on site at supplier, and in the office.
  • Manage and co-ordinate the QMS SCAR processes, being the company contact point for such matters with both Internal Stakeholders and Suppliers.
  • Oversee and co-ordinate the proper completion, retention and review of supplier agreements, along with the relevant internal stakeholders.
  • Support innovation and new product introduction related to supplier selection and monitoring
  • Provide input to the QA Monthly report, by providing line management with regular status updates and KPI measures.
  • Support the Quality Manager regarding the liaising with Notified Body and Competent Authority as required
  • Support Internal audit program as required as both support and lead auditor.
  • Represent the UK Businesses at all external agency and customer inspections.
  • Support the QA initiative to imbed a QA culture throughout the organisations

Quality System

  • Maintain files and records in accordance with relevant QMS procedures and make them available for review during Quality Audits.
  • Support, where required, investigations into quality issues in manufacturing or customer complaints
  • Comply with all applicable QMS processes at all times

Health & Safety

  • Following all Health & Safety guidelines within the Department and notifying the Company of any incident, accident or near miss.
  • To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy

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 adhere to the company’s Quality policy and Environmental policy
  • To undertake other duties as may be reasonably required

 

KEY SKILLS

Essential

  • Previous experience of supplier management in a regulated industry - ideally Medical Device Manufacturing Company, with knowledge of ISO13485 & 21CFR820.
  • Experience of conducting / leading Supplier Quality Audits and internal audits
  • Strong command of written English
  • Excellent verbal communication skills
  • Excellent organisational and planning skills to deliver on a dynamic supplier audit schedule and completion of subsequent documentation.
  • Competent in the use of Microsoft office packages
  • Full driving license

Desirable

  • IRCA Approved Lead Assessor Qualified
  • Experience of problem-solving and risk management methodologies

 

KEY WORKING RELATIONSHIPS

Internal

  • Quality Management
  • Manufacturing
  • Regulatory Affairs
  • Supply Chain
  • Procurement

External

  • Suppliers
  • Notified Bodies and Competent Authorities
  • Contractors
  • 3rd party Clients

 

ADDITIONAL INFORMATION

  • Regular Business travel required – circa 50%
  • This role can be based in Cardiff, Coleraine or Comber.

 

COMPETENCIES

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

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 themselves heard, often playing a leading and influential role in debate and discussion.

Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships.  Doesn’t give up easily in the face of opinions that differ from their own.  Influences others to reach conclusions and gain agreements.

Technical expert –full breadth of technical knowledge and can operate as a technical advisor, influencing others to achieve goals without relying on hierarchy. Keeps up to date on changes within their field and implements plans to ensure organisation is in a state of readiness.  Participates in industry and professional associations

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