Project Quality Lead Engineer

Project Quality Lead - PPAP focused (Production Part Approval Process)
Belfast (Some occasional travel may be needed for business needs)
£42-47K + 10% Bonus + 9% company pension contributions + Private Healthcare + Educational / Training assistance etc
Monday to Friday - 37.5 hours a week with full flexitime (based on 10-4 core hours M-T and 10-2 F)
Top international Medical Device Company - awarded one of the top ranked companies to work for across the world!

Our Client is a top renowned, Medical Device company with bright spacious offices and pristine manufacturing facilities just outside Belfast. They offer job security, stability, training, development and a company culture that well surpasses most companies you will have had exposure to in your career to date - with this in mind; the right personality, attitude and approach to others and your career are key to successfully applying for this role.

The quality team within this company is just over 20 employees in total currently - made up of various levels and specialities.

Due to extensive expansion and growth across the company that has came from high demand for their bespoke products, they are seeking an experienced Project Quality Lead (The company officially calls it a Staff Quality Engineer and it is above the level of Senior Quality Engineer, yet below their Quality Manager level). The role is very much a leading role that is project quality improvement focused, particularly towards ensuring quality and compliance from supply - hence PPAP experience being a preference.
The role is to provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

The role of Project Quality Lead Engineer:

• Work closely with operations and the business functions to ensure quality performance of product and processes
• Collaborate with Divisional QA, cross functional and suppliers' teams to address top quality issues
• Own identified internal and supplier non-conformances and manage the timely closure of NC's
• Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure
• Disposition non-conforming product within MRB, issuing NCs as appropriate
• Communicate and collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required
• Engage in the development and improvement of internal manufacturing processes for existing products
• Performs critical assessment of internal and supplier proposed change management activities
• Performs PPAP activities for supplier changes
• Participates and may lead in the creation and/or review of new or modified procedures
• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary
• Support execution and analysis of manufacturing related complaints and product field actions
• Support and drive Human factor practices, familiarity in the science of Human Factor identification, reduction and mitigation
• Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification
• Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations
• Support the creation and maintenance of inspection methods and sampling
• Applies statistical methods of analysis and process control to current operations
• Engage and interface in internal and external audits providing subject matter expertise
• Support the development and review of process and equipment validation/qualification and MSA of internal processes
• Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities
• Responsible for initiation, internal containment, and support of Commercial holds for potential product escapes
• Drive continuous improvement actions to reduce manufacturing defects
• Provide leadership and subject matter expertise in QA activities to the overall site

Essential requirements for the role of Project Quality Lead Engineer:

• Minimum of 5 years' experience in a similar quality role to a senior level
• Experience within a heavily regulated industry
• BS in a science, engineering or related discipline
• Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics)

Desirable (But not essential) requirements for the role of Project Quality Lead Engineer:

• MS, CQE, or CRE
• Experience in Electronics
• Experience in interacting with regulatory agencies is desired - FDA, MoH, TUV, etc
• Understanding of US and International Medical Device Regulations
• Familiarity with ISO 13485, GDP, GMP

If this role is of interest; or if you have a relatable skillset that might match other similar vacancies; then please send an updated CV via the link on the page, or get in touch with Hugh Nugent to discuss in absolute confidence

Hugh has 11+ years' experience specifically in Engineering / Manufacturing Recruitment and specialises across Senior Executive Placements, Design/Development and Quality Engineering roles throughout Ireland.

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This role would be particularly suitable for those from the Belfast, Bangor, Holywood, Co Down, Antrim, Carrickfergus, Larne, Lisburn areas.