206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Full-timeOn-siteManagement
Eysins
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BEBecton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
Eysins
from CHF 158,600 - 253,775 / year
Full-timeOn-siteSenior
Nejo AI Summary
Quality oversight for contract manufacturing of medical electromechanical instrumentation at a medical technology leader, including supplier qualification and FDA inspections. Valid Swiss work authorization and 10+ years in electromechanical instrumentation manufacturing required. Global scope, driving quality excellence with Lean/Six Sigma methodologies.
Requirements
- Valid Swiss work visa or existing work authorization
- ~10 years senior experience in regulated industries
- Deep expertise in QMS, product design, manufacturing, supply chain
- Extensive knowledge of medical device regulations
- Strong leadership skills
- Strong project management skills
- Strong cross-regional coordination skills
- Emotional intelligence
- Ability to influence stakeholders in complex environments
- Ability to build and inspire high-performing teams
- Bachelor’s degree in a technical field (Engineering preferred)
- Master’s degree a plus
- 10+ years experience in electromechanical instrumentation manufacturing
- 10+ years experience in quality assurance in regulated industries
- 10+ years experience in regulatory compliance in regulated industries
- Strong QMS expertise
- Product design knowledge
- Manufacturing knowledge
- Supply chain knowledge
- Ideally electromechanical knowledge
- Deep knowledge of ISO 13485
- Deep knowledge of FDA QSR (21 CFR Part 820)
- Deep knowledge of ISO 14971
- Deep knowledge of international medical device regulations
- Strong leadership skills
- Strong project management skills
- Strong cross-regional coordination skills
- Ability to influence stakeholders and drive results in complex environments
Tasks
- Lead and develop a Contract Manufacturing Quality team
- Qualify new suppliers
- Conduct supplier audits
- Manage supplier performance
- Champion continuous improvement initiatives
- Apply Lean, Six Sigma, and advanced quality methods
- Partner with design, manufacturing, and supply chain leaders
- Coordinate with procurement leaders
- Resolve challenges across functions
- Enhance supplier capabilities
- Represent the organization during FDA inspections
- Represent the organization during notified body inspections
- Report key metrics and trends to senior leadership
- Shape long-term strategy
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- QMS
- ISO 13485
- FDA QSR (21 CFR Part 820)
- ISO 14971
- Electromechanical instrumentation
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Becton, Dickinson and Company 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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BEBecton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
Eysins
from CHF 158,600 - 253,775 / year
Full-timeOn-siteSenior
Nejo AI Summary
Quality oversight for contract manufacturing of medical electromechanical instrumentation at a medical technology leader, including supplier qualification and FDA inspections. Valid Swiss work authorization and 10+ years in electromechanical instrumentation manufacturing required. Global scope, driving quality excellence with Lean/Six Sigma methodologies.
Requirements
- Valid Swiss work visa or existing work authorization
- ~10 years senior experience in regulated industries
- Deep expertise in QMS, product design, manufacturing, supply chain
- Extensive knowledge of medical device regulations
- Strong leadership skills
- Strong project management skills
- Strong cross-regional coordination skills
- Emotional intelligence
- Ability to influence stakeholders in complex environments
- Ability to build and inspire high-performing teams
- Bachelor’s degree in a technical field (Engineering preferred)
- Master’s degree a plus
- 10+ years experience in electromechanical instrumentation manufacturing
- 10+ years experience in quality assurance in regulated industries
- 10+ years experience in regulatory compliance in regulated industries
- Strong QMS expertise
- Product design knowledge
- Manufacturing knowledge
- Supply chain knowledge
- Ideally electromechanical knowledge
- Deep knowledge of ISO 13485
- Deep knowledge of FDA QSR (21 CFR Part 820)
- Deep knowledge of ISO 14971
- Deep knowledge of international medical device regulations
- Strong leadership skills
- Strong project management skills
- Strong cross-regional coordination skills
- Ability to influence stakeholders and drive results in complex environments
Tasks
- Lead and develop a Contract Manufacturing Quality team
- Qualify new suppliers
- Conduct supplier audits
- Manage supplier performance
- Champion continuous improvement initiatives
- Apply Lean, Six Sigma, and advanced quality methods
- Partner with design, manufacturing, and supply chain leaders
- Coordinate with procurement leaders
- Resolve challenges across functions
- Enhance supplier capabilities
- Represent the organization during FDA inspections
- Represent the organization during notified body inspections
- Report key metrics and trends to senior leadership
- Shape long-term strategy
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- QMS
- ISO 13485
- FDA QSR (21 CFR Part 820)
- ISO 14971
- Electromechanical instrumentation
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Becton, Dickinson and Company 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
Becton, Dickinson and Company
Industry
Healthcare
Description
The company is a global leader in medical technology, advancing health through innovation in medical discovery, diagnostics, and care delivery.
Not a perfect match?
- 206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Full-timeOn-siteManagementEysins - Becton, Dickinson and Company
Senior Continuous Improvement Manager – Global Supply Chain(m/w/x)
Full-timeOn-siteManagementEysinsfrom CHF 143,900 - 230,225 / year - 206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Full-timeOn-siteSeniorEysins - SUSONITY
Director Vendor Delivery and Alliance Management(m/w/x)
Full-timeOn-siteSeniorEysins - BD Biosciences
EMEA Senior Marketing Manager Life Science Research(m/w/x)
Full-timeOn-siteSeniorEysinsfrom CHF 160,000 - 205,000 / year