Quality Engineer

At Eakin Healthcare, we put our patient at the heart of everything we do. Fifty years ago, it all started with one man’s mission: pharmacist, Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formulated what would become the game-changing, eakin Cohesive seal. Fast forward to today, and we’re still keeping it in the family. We’ve grown a lot since then, both organically and through acquisitions. We now have a team of over 700 colleagues across three manufacturing sites and 12 sales and distribution centres. We’re making a difference in three therapeutic areas: Ostomy, Respiratory, and Surgical. We’re proud to export our innovative products to over 60 countries through a network of 40 distributors plus our own offices in Japan, The Netherlands, France, Germany, Belgium, and Luxembourg.

We’re good at what we do – come and join us and you can benefit from:

• Blended Working
• Bonus
• 25 days holiday plus bank holidays (rising to 28)
• Option to buy holiday days
• 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 Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. Working in close partnership with our Research & Development and Manufacturing teams to ensure all quality and regulatory requirements are in place for all new products. You will be responsible for reviewing and improving our systems within the Comber plant, implementing change where appropriate and ensuring compliance with the Quality Management System. This role will suit an individual who can quickly build professional working relationships, works well as part of a team and can investigate and implement improvement activities.

KEY ACTIVITIES

• Quality processes: Work with other departments as required to implement, enhance and maintain relevant processes as required by the quality management system. Review quality processes and recommend improvements to quality, efficiency and output. Carry out audits of relevant processes as per schedule and implement improvements as required. Investigate internal and external quality issues and document root cause and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements. Assist with process and software validation activities, providing guidance to relevant personnel ensuring appropriate protocols and reports are completed. Establish/update documented procedures as required and ensure appropriate training is completed. Identification, investigation and documentation of product and process non-conformances.
• Production support: Provide regular and ad hoc feedback on quality related issues and work with relevant personnel to ensure compliance and implement improvements. Assist with the implementation of product and process changes, ensuring that quality system requirements are maintained. Develop and monitor quality metrics and implement improvement activities as required, in collaboration with relevant personnel.
• New Product Introduction (NPI): Work as part of the NPI team to ensure that quality and regulatory requirements are known, understood and adhered to during the NPI process. Support the development of appropriate documents to describe and control quality and regulatory aspects of NPI.
• Communication: Communicate clearly (both in writing and verbally) to all levels on quality related issues. Liaise with other companies within the Eakin Healthcare business to develop, implement and maintain group processes and techniques to reflect best practice, in areas including Quality, Health & Safety and Environmental management.
• 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

• A degree / HND or equivalent qualification in an engineering, scientific or related discipline.
• Proven experience in a volume manufacturing environment as a Quality Engineer or similar.
• Experience of using problem solving and root cause analysis tools (8D, FMEA etc).
• Strong interpersonal and communication skills.
• Able to quickly build effective professional working relationships.
• Experience in a medical device / life sciences environment.
• Knowledge of standards and regulatory requirements associated with medical devices e.g. ISO13485, ISO14971, EU MDR, FDA QSR.
• Experience in use of Minitab or similar statistical analysis software.
• Quality auditing certification.
• Experience of using lean manufacturing / improvement tools such as 5S, Six Sigma, Kaizen, process mapping.

KEY WORKING RELATIONSHIPS

• Internal: R & D – to ensure that quality and regulatory requirements are met during new product introduction projects. Production – to liaise with production personnel at all levels to ensure requirements for quality are defined and met. Develop, implement and maintain appropriate quality metrics.
• External: Dealing with suppliers to discuss quality related issues and improvements. Dealing with customers and third-party auditors during quality audits.

ADDITIONAL INFORMATION

Occasional travel to other Eakin Healthcare sites and to supplier premises may be required. Access to transport.

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.