MGR I QLTY & RELIABILITY ENGINEERING MGR I QLTY & RELIABILITY ENGINEERING

TE Connectivity (Galway, Ireland) 16 days ago

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 $13 billion 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 nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 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/

Job Overview

Job Title: Quality Systems Manager 

Reporting to the Quality Director the Quality Systems Manager will be the responsibility for maintaining and driving continuous improvement of the Plants Quality System. The Quality Systems Manager is responsible for the administration, supervision, and development of the Galway Quality Systems functions.  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.  
 

Job Responsibilities
  • Ensuring that the quality system requirements are effectively established and effectively maintained in accordance with FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD) Sch3, MDR and any other applicable regulations
  • Report on the performance of the Quality System to Plant Management
  • Promote awareness of the applicable regulatory requirements and quality management system requirements throughout the organisation
  • Ensure compliance to the MSDAP Program
  • Develop and implement 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 
    • Documentation associated with these functions
  • Develop, track, and report on the following administrative systems:
    • Department metrics
    • Department objectives
    • Personnel development and training
  • Support regulatory agency and customer quality audits
  • Act on behalf of Plant Management during audits
  • Ensure all aspects of the site QMS are managed and developed in line with regulatory standards, and ensure a culture of continuous improvement is in place to drive improved effectiveness and efficiency (this includes areas such as Document Control, Deviations, Complaints etc)
  • Responsible for Quality audit function
  • Responsible for Document Control function
  • Responsible for Training administration
  • Responsible for Customer Complaint Management
  • 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 Action program
  • Utilize formal problem-solving techniques to resolve process-related issues
  • As required, lead cross-functional teams to support the resolution of product and/or process-related issues or objectives.
  • Be 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 
What your background should look like:
  • Bachelors Degree in Science, Engineering or related subject
  • 5+ years relevant supplier quality/quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry
  • Ability to work as a 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.  

#IJ

Competencies
Building Effective Teams
Motivating Others
Managing and Measuring Work
Values: Integrity, Accountability,Teamwork, Innovation
SET : Strategy, Execution, Talent (for managers)

What TE Connectivity offers:

We offer competitive rewards & compensation. Our commitment to our employees includes offering benefit programs that are comprehensive, competitive and will meet the needs of our employees.

  • Competitive Salary Package
  • Performance-Based Bonus Plans
  • Health and Wellness Incentives
  • Employee Stock Purchase Program
  • Community Outreach Programs / Charity Events
  • Employee Resource Groups

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