MGR II QUALITY

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.

The MGR II Quality Assurance - Microbiology & Sterilization is responsible for leading and supporting the Microbiology and Sterilization team and activities within TE Medical. This includes establishing, implementing, and maintaining the Microbiology and sterilization team, strategy, policies, and processes within the TE Medical Business Unit while ensuring compliance with the relevant regulations and standards. The MGR II Quality Assurance - Microbiology & Sterilization will develop and lead cross-site improvement activities and drive best practice adoption. 

Tasks and Responsibilities:

• Works with cross-functional and cross-site teams to improve quality system processes related to sterilisation and environmental monitoring.
• Mentors and trains staff associates to perform effectively in their work and ensures the training is documented.
• Engages and manages the quality microbiology and sterilization team. Creates a strong team working environment with focus on customer needs, compliance, quality, and risk mitigation.
• Implements changes to the QMS as driven by internal and external factors.
• Drives harmonization of QMS processes; works with sites to develop implementation plans, ensure site activities are completed as planned, monitor implementation and effectiveness.
• Provides support with respect to validation of product in approved sterilization cycles.
• Carry out training on harmonized processes as required.
• Assists in ensuring all sites are “audit ready”. 
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving issues related to Sterilisation and Environmental Monitoring Processes
• Proactively liaises with Quality leaders and local implementation project teams to ensure project milestones are met.
• Leads site environmental monitoring, endotoxin, and bioburden programs.
• Provide guidance to the sites on cleanroom and purified water systems control with respect to monitoring, routine operations, impact of non-conformances and assessment of change.
• Develop talent by creating training and development plans with associate input into their career objectives
• Takes part in Global Compliance projects as needed.
• Provides guidance on biocompatibility as required.
• Reporting directly to the Global Head of Quality - Devices.
   

Qualifications and Experience Required:

• Bachelor’s Degree with a scientific or microbiology emphasis 
• 10+ years in a similar role within the Medical Device or related industry supporting environmental monitoring and sterilization processes 
• Working knowledge of regional and international quality system requirements including 21CFR 820, ISO 13485, ISO 11135, ISO 11737-3, ISO 10993, and ISO 14644-1
• Lead Auditor ISO 13485 certification is a plus
• Must have a good understanding of quality system requirements and how each quality system element connects. 
• Well organized with strong ability to prioritize tasks and work on own initiative. 
• Strong networking skills and organizational awareness- Must be able to work effectively with individuals at all levels and across multiple locations within the global organization. 
• Excellent interpersonal skills – must be able to understand the opinions and perspectives of internal and external stakeholders and influence others.
• Strong team building skills with proven abilities in decision making.
• Strong organization, presentation, and communication skills 
• Creative and innovative thinking skills
• Willingness to travel domestically and internationally as needed (10-15% of time)
• Ability to work flex work hours as needed to support global sites across time-zones

Competencies