Supplier Quality Engineer

ABOUT THE ROLE

Reporting to the Quality Assurance Manager, the SQE will work closely with the Supplier base of the Eakin Healthcare Companies in Coleraine & Comber, 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.

KEY ACTIVITIES

• Create, implement and manage a risk-based Supplier Audit Schedule in Coleraine & Comber.
• 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 remotely.
• 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 QARA Managers regarding the liaising with Notified Body and Competent Authority as required.
• Collaborate with the introduction/function/improvement of the AQL sample inspection program for supplied components.
• Support Internal audit program as required as both support and lead auditor.
• Represent the Northern Ireland 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, MDSAP, EUMDR, EUMDD, UKCA & 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
• Knowledge of and experience with CAPA process, including formal root cause analysis.
• Experience of leading audits within a regulated or manufacturing environment

KEY WORKING RELATIONSHIPS

• Quality & Regulatory, Operations and Supply Chain

External

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

ADDITIONAL INFORMATION

• Regular Business travel required to Coleraine & 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.

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.

Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively.