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Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- FDA
- ISO 13485
- EU MDR
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Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- FDA
- ISO 13485
- EU MDR
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
INTEGRA LIFESCIENCES CORP
Branche
Healthcare
Beschreibung
The company is focused on improving healthcare outcomes through innovative solutions.
Noch nicht perfekt?
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Vollzeitnur vor OrtSeniorLe Locle - Bristol Myers Squibb
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Vollzeitnur vor OrtBerufserfahrenBoudry - Bristol Myers Squibb
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Vollzeitnur vor OrtJuniorBoudry