Principal Supplier Quality Engineer.

2 weeks ago

Galway, Ireland Medtronic Full time

Medtronic
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Our Purpose 
The Diabetes Supplier Quality Department in Medtronic, plc, partners and builds a collaborative relationship with Medtronic’s suppliers to deliver the highest quality and most reliable products to our customers through a global supply chain.
The Principal Supplier Quality Engineer works with a Supplier Quality team who works with external suppliers and in a cross-functional Medtronic team daily to resolve supplier related issues, drive continuous improvement while driving key quality metrics. They will liaise with our extensive network of suppliers and cross functional Medtronic teams to execute component validations, drive. 
quality improvements, cost savings, while managing and implementing Supplier driven changes.

Come for a job, stay for a career

Location: Full time Onsite in Galway

A Day in The Life Of:
Ensures that suppliers deliver quality parts, materials, and services.

Provide Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects. Qualifies and onboards suppliers according to company standards during NPD pre-production and development phases, to ensure high supplied product yield and reliability. Executes validation activities at supplier and contract manufacturers to Medtronic requirements ensuring high product quality and resolve supplier-related problems as they occur. Develops and prioritizes a supplier auditing schedule during NPD to ensure that designated suppliers are audited and onboarded to the Diabetes ASL per Medtronic and medical device requirements while ensuring good manufacturing practices (GMP) and quality standards are met at the suppliers. Collaborates with Component Engineers to perform risk assessment, establish quality impact, develop, and deliver the Product Acceptance Sampling and validation Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products. Drive supplier improvement/corrective action through the following activities: Work with the supply base to drive corrective/preventative action based on feedback from incoming inspection, Medtronic/supplier internal quality metrics and customer complaints.Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory. requirements are met and properly documented.Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes).Provide technical assistance to suppliers/other resources performing qualification/validation testing. Ensure the resolution of all issues raised during testing/qualification. Represent the Supplier Quality group in operating meetings providing status updates on supplier base. Support supplier visits or audits as required. Support external regulatory and internal audits as required. You will work with supplier and sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device
quality. Work with the Enterprise Supplier group supporting creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for improvements.

Key Skills & Experience 

Qualified to Level 8 in Science, Engineering, or relevant discipline. 7+ years Engineering and/or Quality experience in the medical industry or related field, or Level 9 degree with 5+ years’ experience. Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. You are a dynamic team player and can work effectively and proactively on cross functional teams within minimum supervision. Experience with knowledge in Lean Principles and statistical analysis. Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV). Experience with Agile, SAP & Microsoft Project an advantage. Excellent problem-solving skills are desirable. You are a good communicator and fluent in English, both verbal and written.

Nice to Have 

Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is an advantage. Previous experience in Supplier Quality and leading teams ISO 13485 Lead Auditor Certification, and experience performing audits at suppliers and/or contract manufacturers. Previous experience in injection molding processes, PCBA processes and product transfers to Contract manufacturers.

Medtronic offer a competitive salary and flexible Benefits Package

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