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At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Contract Type
12 Month Fixed Term Contract
Job Overview
The Quality System Manager is responsible for managing the processes and people within the Quality Systems dept to ensure that the company is in compliance with all applicable regulatory and business requirements.
Duties & Responsibilities:
* Site Management Representative
* Ensuring that the quality system requirements are effectively established and effectively maintained in accordance with FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 665/2022, MHLW MO 169, TG(MD) Sch3, MDR and any other applicable regulations
* Reporting to top management on the effectiveness of the quality management system and any need for improvement.
* Ensure compliance to the MSDAP Program
* Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
* Sign-off authority for changes to procedures, processes, designs, etc.
* Authority to act on behalf of top management during the audit
* Authority to place products or processes on hold
* Responsibility for managing quality audit functions
* Responsibility for contributing to corrective and preventive action activities, complaint handling and the handling of nonconforming product, etc.
* Communicates with external parties on matters relating to the quality system and ISO 13485:2016 registrations.
* Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.
* 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 665/2022, MHLW MO 169, TG(MD) Sch3/ MDD, MDR Standards.
* 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).
* Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department. This includes motivation, training and appraisal of QS staff.
* Responsible for processes within Document Control, Customer Quality and Master Data area.
* To take a leadership role in driving improvement initiatives in the Quality Management system across the site.
* Drive and enhance a compliance culture though-out the site.
* Providing Quality Systems support for all business units and sites.
* Preparing for and supporting external audits (TUV, FDA, customer etc).
* Ensure adequate monitoring and measurement of processes and reporting same to management.
* Ensure Quality System processes are lean, compliant, user-friendly and are well understood through-out the organization.
* Be responsible for Health & Safety within assigned areas
* Any other duties assigned from time to time
What your background should look like:
Education/Experience:
* Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification in Quality Assurance.
* Experienced Quality Systems Manager with a minimum of 3 years’ experience at that level within the Medical Device or related industry.
Key Requirements:
* Excellent working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements.
* Regulatory experience / knowledge.
* Good organization, supervisory, technical writing and investigation skills are required.
* Excellent communication and inter-personal skills.
* Proven ability to influence.
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Contract Type
12 Month Fixed Term Contract
Job Overview
The Quality System Manager is responsible for managing the processes and people within the Quality Systems dept to ensure that the company is in compliance with all applicable regulatory and business requirements.
Duties & Responsibilities:
1. Site Management Representative
2. Ensuring that the quality system requirements are effectively established and effectively maintained in accordance with FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 665/2022, MHLW MO 169, TG(MD) Sch3, MDR and any other applicable regulations
3. Reporting to top management on the effectiveness of the quality management system and any need for improvement.
4. Ensure compliance to the MSDAP Program
5. Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
6. Sign-off authority for changes to procedures, processes, designs, etc.
7. Authority to act on behalf of top management during the audit
8. Authority to place products or processes on hold
9. Responsibility for managing quality audit functions
10. Responsibility for contributing to corrective and preventive action activities, complaint handling and the handling of nonconforming product, etc.
11. Communicates with external parties on matters relating to the quality system and ISO 13485:2016 registrations.
12. Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.
13. 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 665/2022, MHLW MO 169, TG(MD) Sch3/ MDD, MDR Standards.
14. 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).
15. Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department. This includes motivation, training and appraisal of QS staff.
16. Responsible for processes within Document Control, Customer Quality and Master Data area.
17. To take a leadership role in driving improvement initiatives in the Quality Management system across the site.
18. Drive and enhance a compliance culture though-out the site.
19. Providing Quality Systems support for all business units and sites.
20. Preparing for and supporting external audits (TUV, FDA, customer etc).
21. Ensure adequate monitoring and measurement of processes and reporting same to management.
22. Ensure Quality System processes are lean, compliant, user-friendly and are well understood through-out the organization.
23. Be responsible for Health & Safety within assigned areas
24. Any other duties assigned from time to time
What your background should look like:
Education/Experience:
25. Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification in Quality Assurance.
26. Experienced Quality Systems Manager with a minimum of 3 years’ experience at that level within the Medical Device or related industry.
Key Requirements:
27. Excellent working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements.
28. Regulatory experience / knowledge.
29. Good organization, supervisory, technical writing and investigation skills are required.
30. Excellent communication and inter-personal skills.
31. Proven ability to influence.
Competencies
Building Effective TeamsManaging and Measuring WorkMotivating OthersValues: Integrity, Accountability, Inclusion, Innovation, TeamworkSET : Strategy, Execution, Talent (for managers)
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.
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