QUALITY SYSTEMS ANALYST II

Job Overview

TE Connectivity's Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.

We are looking for an individual to join our Quality Management System (QMS) team where they will assist with the day to day operations of the QMS and ensure it’s compliance with the appropriate internal and external regulatory requirements.

Responsibilities and Duties

• Maintain document control, process change management plans and distribute hard copies.
• Maintinain CAPA and Non-conforming (NC) Processes, training, timelines and metrics. Send status communications to the site teams.
• Provide technical support to owners, including identification of root causes, corrective actions, and implementation.
• Maintain internal and external audit process, schedule audits and initiate and assign non-conformances.
• Perform and/or provide support in internal and external audits within the company to ensure compliance to applicable regulatory and corporate standards/requirements and ISO.
• Compile, analyze and report quality metrics.
• Communicate significant issues or developments identified during quality assurance audits and recommend process improvements to the Quality Management.
• Work across several departments with other personnel to obtain or share data; be willing to seek out and engage with others daily.
• Identify and recommend solutions to process to improve efficiency and quality of operations while reducing waste when possible.
• Participate in QMS training for new employee orientation.
• Other duties as assigned by manager.

What your background should look like:

• Bachelor's degree in a related discipline
• Three years’ experience in a regulated environment, preferably medical devices or comparable regulatory controls
• Three years experience in document control / document management
• Previous work experience in a cross-functional, team environment collaborating with different roles in a manufacturing environment
• Proficiency with computer systems, including MS Office applications.
• Excellent verbal and written skills with technical terms in a design and manufacturing environment
• Preferred understanding of the quality system requirements of ISO13485:2016 and 21 CFR820
• Preferred ISO13485:2016 auditor training
• Preferred previous work experience investigating non-conformances, determining root cause and applying suitable corrective actions

Competencies