SR QUALITY ENGINEER

Job Overview

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

 

• Deliver on all KPIs that help the business achieve its goal. They may have primary responsibility for specific KPI’s for the business area.
• Lead and drive QA initiatives within area of functional responsibility.
• Provide technical support to the Quality Technicians
• Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.
• Lead, coordinate & maintain risk assessment documentation e.g. FMEA’s, for their assigned product(s)
• Investigate root cause of Quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
• Strategically lead new product introduction and contract reviews from a QA perspective where assigned
• Lead assigned projects from a quality perspective including process improvements, SCN’s, Notification of Changes, Contract Reviews and alternative materials.
• Prepare and updating Operations procedures and associated documentation.
• Responsibility for assigned functional area GMP standards and compliance including the promotion of Quality awareness.
• Establish inspection standards, sampling plans, and test methods.

Other Responsibilities

 

• Report Quality metrics.
• Develop strong links with customer organisations and other project stakeholders.
• Quality review of functional area validation documentation.
• May have responsibility to manage the day to day activities of inspector or student level resources in a safe environment and be responsible for Health and Safety goals.
• Perform and support internal and external audits to ISO and FDA requirements.
• Perform an active role in further development and continuous improvement of the Quality Management system.
• Other tasks as directed by the Operations Quality Manager or Quality Supervisor in line with company goals and objectives.

Qaulificattion

 

• Level 8 degree in Science / Engineering or related fields.
• Minimum of 5 years Quality Engineering experience with 4 Years industry experience in a medical device manufacturing environment

Key Requirements

 

• Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
• Experience in CAPA.
• Experience in root cause analytical and problem-solving skills.
• Knowledge of FDA and ISO Quality systems for Medical device companies desirable.
• New product introduction and manufacturing process transfer experience desirable.
• Test method and process validation experience
• Demonstrated excellent organizational skills and ability to work on own initiative essential.

Excellent written and verbal communication skills essential

Competencies