Quality Operations Engineer Quality Operations Engineer

Job Overview

Job Title: Quality Operations Engineer

Job Overview 

Reporting to the Quality Supervisor, the Quality Operations Engineer is a member of the Operations Quality group. The successful candidate will be responsible for Operations Quality within their prescribed area of functional responsibility. They will be working as part of a team to maintain high quality/performance standards on all Creganna Medical products.
This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance to the Creganna Medical Quality System. The focus of the role is to supply high-quality medical devices and components to deliver an Extraordinary Customer Experience.

TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.

Job Responsibilities

• Working with the Supervisors and Manufacturing Engineering, promote the achievement of the health and safety goals. 
• To deliver on all KPIs that help the business achieve its goal.
• The Operations Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system.
• Establish and maintain risk management principles and methods throughout the product realisation process in compliance with the company’s Quality Management system and ISO14971.
• Maintain relevant documentation to comply with quality standards and customer requirements.
• Offer quality guidance to a team of Quality Technicians in support of the day-to-day manufacturing operations. 
• Develop strong links with customer organisation’s and other project stakeholders.
• Quality review of responsible area validation documentation.
• Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues.
• Overall responsibility for production GMP standards and compliance.
• Establish inspection standards, sampling plans and test methods.
• Prepare and update Operations procedures and associated documentation.
• Support customer audits and surveillance/accreditation audits.
• Conduct audits of the Manufacturing Operation and the Quality System ensuring compliance with ISO13485.
• Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.
   

What your background should look like:

Qualifications

• Level 8 degree in Quality or Degree in Science / Engineering.
• Experience within a similar role as Quality Engineer.
• 3+ years industry experience in a medical device-manufacturing environment.
• Experience working with Catheter products is an advantage.

Key Requirements

• Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies.
• Quality experience in component and device manufacturing desirable.
• Excellent written and oral communication skills essential.

We are an Equal Opportunities Employer
 

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