Integra LifeSciences Switzerland Sàrl
Quality Engineer I(m/w/x)
Full-timeOn-siteExperienced
Le Locle
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ININTEGRA LIFESCIENCES CORP
Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
Le Locle, Rietheim-Weilheim
Full-timeOn-siteSenior
Nejo AI Summary
Implementing compliance frameworks like FDA/ISO 13485 for remediation programs at medical device sites. 10+ years team leadership in highly regulated medical device industries required. Travel across multiple sites.
Requirements
- Bachelor's degree in Engineering, Science, or related technical discipline
- 10+ years of experience leading a team or equivalent education and management experience
- Experience working with Quality Management Systems and compliance
- Experience in highly regulated industries, medical device and/or pharmaceutical preferred
- Experience in implementing remediation programs and compliance frameworks such as FDA, ISO 13485, and EU MDR
- Demonstrated management and communication skills
- Strong attention to detail
- Strong communication and presentation skills
- Ability to travel up to 50% if needed
- Strong computer skills
Tasks
- Develop and manage project plans for ECMP implementation
- Track progress and ensure execution according to the plan
- Report site progress to the ECMP Program Management Office
- Manage ECMP documentation and scheduling at sites
- Coordinate collaborative activities between local site teams
- Review outputs from site work stream activities for alignment with ECMP requirements
- Facilitate resolution of issues
- Perform other assigned duties
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- FDA
- ISO 13485
- EU MDR
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of INTEGRA LIFESCIENCES CORP and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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ININTEGRA LIFESCIENCES CORP
Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
Le Locle, Rietheim-Weilheim
Full-timeOn-siteSenior
Nejo AI Summary
Implementing compliance frameworks like FDA/ISO 13485 for remediation programs at medical device sites. 10+ years team leadership in highly regulated medical device industries required. Travel across multiple sites.
Requirements
- Bachelor's degree in Engineering, Science, or related technical discipline
- 10+ years of experience leading a team or equivalent education and management experience
- Experience working with Quality Management Systems and compliance
- Experience in highly regulated industries, medical device and/or pharmaceutical preferred
- Experience in implementing remediation programs and compliance frameworks such as FDA, ISO 13485, and EU MDR
- Demonstrated management and communication skills
- Strong attention to detail
- Strong communication and presentation skills
- Ability to travel up to 50% if needed
- Strong computer skills
Tasks
- Develop and manage project plans for ECMP implementation
- Track progress and ensure execution according to the plan
- Report site progress to the ECMP Program Management Office
- Manage ECMP documentation and scheduling at sites
- Coordinate collaborative activities between local site teams
- Review outputs from site work stream activities for alignment with ECMP requirements
- Facilitate resolution of issues
- Perform other assigned duties
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- FDA
- ISO 13485
- EU MDR
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of INTEGRA LIFESCIENCES CORP and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
INTEGRA LIFESCIENCES CORP
Industry
Healthcare
Description
The company is focused on improving healthcare outcomes through innovative solutions.
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