Senior Quality Engineer III Senior Quality Engineer III

Job Overview

Job Title: Senior Quality Engineer
Reporting to the Quality Manager, the Senior Quality 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 lead and work as part of a team to maintain high quality/performance standards on all TE Medical products. 
The position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision.
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 the reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, the facility of production, and availability of materials and equipment. Our 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 labour, as well as failure analysis, root cause, corrective action and customer communication.

Job Responsabilities

• Manage the day to day activities of the team in a safe environment and be responsible for Health and Safety goals.
• Deliver on all KPIs that help the business achieve its goal.
• Lead and drive QA initiatives within area of functional responsibility.
• Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.
• Lead, coordinate & maintain risk assessment documentation e.g. FMEA’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.
• Prepare and updating Operations procedures and associated documentation.
• Overall responsibility for functional area GMP standards and compliance including the promotion of Quality awareness.
• Establish inspection standards, sampling plans, and test methods.
• Report Quality metrics.
• Develop strong links with customer organisations and other project stakeholders. 
• Quality review of functional area validation documentation.
• 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.
• Supervision and direction of Quality personnel.
• Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.

What your background should look like:

Qualifications

• Level 8 degree in Science / Engineering or related fields. 
• Minimum of 5 years industry experience in a medical device manufacturing environment.
• People management experience. 

Key Requirements

• Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
• Experience managing and leading a team. 
• Strong CAPA experience.
• Strong root cause analytical and problem-solving skills. 
• Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable.
• New product introduction and manufacturing process transfer experience desirable.
• Demonstrated excellent organizational skills and ability to work on own initiative essential.
• Supervisory experience desirable.
• Excellent written and verbal communication skills essential.

We are an Equal Opportunities Employer

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