Supplier Quality Engineer in Cardiff

At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. We’ve been recognised as a Great Place to Work®! And we’re proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women. At Eakin Healthcare, we’re united by one mission: working together to improve lives - just like we’ve been doing for over five decades.

WHY JOIN US?

• Blended Working Bonus
• 25 days holiday plus bank holidays (rising to 28)
• Option to buy holiday days
• Wellbeing Programme
• Health Cash Plan
• Pension
• Life Assurance
• Enhanced Maternity/Paternity
• Cycle to Work Scheme
• Referral Scheme
• Long Service Awards
• Free Parking

ABOUT THE ROLE

Reporting to the Supplier 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.

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 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.

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

• 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

Internal

• Quality & Regulatory, Operations and Supply Chain.

External

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

ADDITIONAL INFORMATION

Regular business travel required.

COMPETENCIES

• Manages Complexity: Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
• Decision Quality: Making good and timely decisions that keep the organization moving forward.
• Plans and Aligns: Planning and prioritizing work to meet commitments aligned with organizational goals.
• Ensures Accountability: Holding self and others accountable to meet commitments.
• Collaborates: Building partnerships and working collaboratively with others to meet shared objectives.
• Communicates Effectively: Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.
• Persuades: Using compelling arguments to gain the support and commitment of others.
• Being Resilient: Rebounding from setbacks and adversity when facing difficult situations.