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Quality Operations Manager
- Full Time
- Mid-Senior Level
About TE Connectivity
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
Creganna Medical is ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia. http://www.creganna.com/
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.
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.
- 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:
o Delivery of raw materials and components
o Manufactured devices and equipment
o Documentation associated with these functions
- Develop, track, and report on the following administrative systems:
o Department metrics
o Department objectives
o Personnel development and training
- 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 communication skills.
- Excellent problem-solving and innovation skills.
We are an Equal Opportunities Employer
Core Values: Integrity, Accountability, Teamwork, Innovation