Jabil Waterford, County Waterford, Ireland
Overview
The Quality Engineer assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conform to established company, customer and regulatory requirements. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.
Responsibilities
Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA’s & support the generation of DMF’s where appropriate.
Use scrap reduction methodologies and process capability analysis to provide a robust defect free process.
Maintain experience in sterilisation, automation, equipment/software validation.
Support the external and internal Quality Management System auditing function (auditor trained).
Involve in supporting the CAPA system.
Collaborate with other departments to drive quality inputs and initiatives into overall operations.
Support the implementation of Company Policies and GMP.
Support safety and quality programs and initiatives; ensure ongoing GMP compliance in practices and record-keeping.
Apply root cause problem solving in a team environment and align customer specifications with JABIL capabilities.
Other responsibilities may be assigned as needed.
Qualifications
Degree in Engineering / Science (Mechanical / Electronics / Chemistry).
2 to 4 years’ experience in a Quality Engineering role.
Fully competent in Quality Management Standards.
Skills/Attributes
Leadership, ability to motivate team members; energetic and enthusiastic.
Excellent organization, communication, computer and presentation skills.
Strong initiative, decision-making, and ability to work in a core team environment.
Solution-driven with emphasis on performance and results.
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