- Health and Safety - focus in line with plant objectives to ensure initiatives are successful and agreed targets are achieved. This includes accident reduction and 5S+1 program success.
- TEOA (TE Operating Advantage) – lead and support the program to achieve the star ratings through implementation of tools through the business, and drive performance improvements through the use of these tools.
- Works with the business unit and Engineering Manager to achieve the cascaded Plant objectives.
- Develop Quality Operations Strategy for the business unit.
- Drive a Quality continuous improvement and innovation culture.
- Lead and support Cost of Poor-Quality initiatives.
- Develop strong links with customer organisations.
- Ensure compliance to the Quality Management system in all activities.
- Participate in new product introductions to ensure quality is built into all products early in their life cycle.
- Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
- Management and continued development of Quality staff.
- Promote awareness of the applicable regulatory requirements and Quality Management system requirements throughout the organisation.
- Develop and implement Manufacturing procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: Delivery of raw materials and components, Manufactured devices and equipment and Documentation associated with these functions.
- Develop, track, and report on Department metrics, Objectives and personnel trainings.
- Support regulatory agency and customer Quality audits. Act on behalf of Plant Management during audits.
- Authority to place products or processes on hold.
- Design and develop forms and instructions for recording, evaluating, and reporting quality data.
- Manage Corrective and Preventive Actions.
- Drive the utilization of formal problem-solving techniques to resolve process-related issues.
- As required, lead cross-functional teams to support resolution of product and/or process-related issues or objectives.
- Level 8 degree in Science, Engineering or related subject.
- 7+ years relevant Quality Operations experience in GMP Manufacturing environment in Medical Device/Pharma industry.
- Strong people management experience.
- Regulatory audit facing experience.
- Innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD) Sch3/ MDD, MDR Standards.
- Ability to work as a proactive team member.
- Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
- Good organization and investigation skills are required.
- Excellent problem-solving and innovation skills.
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quality manager - GALWAY, Ireland - TE Connectivity
Description
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
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.
Reporting to the Quality Director, the Quality Operations Manager will be responsible for maintaining and driving continuous improvement of Creganna Medical's product Quality and Compliance. The Quality Operations Manager will ensure a culture of continuous improvement is in place to drive improved compliance, effectiveness and efficiency.
This position is responsible for ensuring full procedural compliance to the regulatory requirements of 21 CFR 820, ISO13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD)R sch3 and other applicable regulations.
RESPONSIBILITIES AND DUTIES:
KNOWLEDGE AND EXPERIENCE REQUIRED:
ABOUT TE CONNECTIVITY
TE Connectivity is a global technology leader enabling a secure, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions have been proven in the most demanding environments, enabling advancements in transportation, industrial applications, medical technology, energy technology, data communications, and for the home. With more than 85,000 employees, including more than 7,500 engineers, we work with customers in nearly 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at and on LinkedIn, Facebook, WeChat and Twitter.
WHAT TE CONNECTIVITY OFFERS:
We are pleased to offer you an exciting total package that can also be flexibly adapted to changing life situations - the well-being of our employees is our top priority
• Competitive Salary Package
• Performance-Based Bonus Plans
• Health and Wellness Incentives
• Employee Stock Purchase Program
• Community Outreach Programs / Charity Events
• Employee Resource Group
Across our global sites and business units, we put together packages of benefits that are either supported by TE itself or provided by external service providers. In principle, the benefits offered can vary from site to site.
