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Quality Manager(m/w/x)
Leading site quality for medical device and combination product manufacturing. Medical device or combination product quality experience, plus ASQ or Six Sigma Black Belt certification required. Building quality systems from scratch for a new healthcare entity.
Requirements
- Bachelor’s degree or higher
- Fundamental Medical Device, Pharmaceutical, or Combination Product experience in a Quality function
- Quality management experience demonstrating team leadership
- ASQ Certified Quality Engineer, ASQ Certified Manager of Quality/Organizational Excellence, or Certified Six Sigma Black Belt
- Skills in Competent Authority Interaction and Influence, External Audit Readiness & Management, Medical Device, Nonconforming Material Control, Customer Interaction and Support, Quality Engineering, Process Validation, Process Control & Monitoring, Risk Reduction, Continuous Process and Product Improvement, Field Actions & Recalls, and Organizational Leadership
- Demonstrated successful organizational influence in compliance excellence, continuous improvement, product-related risk mitigation, and process capability and efficiency enhancement
- Strong verbal and written communication skills
- Strong leadership, decision-making, problem-solving, continuous improvement, and management skills
Tasks
- Serve as the Quality Management Representative for the manufacturing site
- Lead the site Quality team and provide expert-level guidance
- Supervise quality engineering professionals and set performance objectives
- Interpret product and performance data to respond to customer needs
- Resolve nonconformances and support business objectives
- Drive continuous improvement by defining guidelines and priorities
- Initiate and approve improvement projects for product and process capabilities
- Identify and lead compliance improvement opportunities for quality regulations
- Guide internal teams in developing quality strategies for medical devices
- Maintain effective Quality metric performance and resolve performance issues
- Provide peer leadership to enhance compliance and risk management
- Utilize industry technologies for process control and trend analysis
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
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Quality Manager(m/w/x)
Leading site quality for medical device and combination product manufacturing. Medical device or combination product quality experience, plus ASQ or Six Sigma Black Belt certification required. Building quality systems from scratch for a new healthcare entity.
Requirements
- Bachelor’s degree or higher
- Fundamental Medical Device, Pharmaceutical, or Combination Product experience in a Quality function
- Quality management experience demonstrating team leadership
- ASQ Certified Quality Engineer, ASQ Certified Manager of Quality/Organizational Excellence, or Certified Six Sigma Black Belt
- Skills in Competent Authority Interaction and Influence, External Audit Readiness & Management, Medical Device, Nonconforming Material Control, Customer Interaction and Support, Quality Engineering, Process Validation, Process Control & Monitoring, Risk Reduction, Continuous Process and Product Improvement, Field Actions & Recalls, and Organizational Leadership
- Demonstrated successful organizational influence in compliance excellence, continuous improvement, product-related risk mitigation, and process capability and efficiency enhancement
- Strong verbal and written communication skills
- Strong leadership, decision-making, problem-solving, continuous improvement, and management skills
Tasks
- Serve as the Quality Management Representative for the manufacturing site
- Lead the site Quality team and provide expert-level guidance
- Supervise quality engineering professionals and set performance objectives
- Interpret product and performance data to respond to customer needs
- Resolve nonconformances and support business objectives
- Drive continuous improvement by defining guidelines and priorities
- Initiate and approve improvement projects for product and process capabilities
- Identify and lead compliance improvement opportunities for quality regulations
- Guide internal teams in developing quality strategies for medical devices
- Maintain effective Quality metric performance and resolve performance issues
- Provide peer leadership to enhance compliance and risk management
- Utilize industry technologies for process control and trend analysis
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
About the Company
DEU 3M Healthcare Germany GmbH
Industry
Healthcare
Description
The company is a new healthcare entity with a legacy of creating breakthrough solutions to improve lives and support healthcare professionals.
Not a perfect match?
- Lubrizol Corporation
Quality Manager(m/w/x)
Full-timeOn-siteSeniorWeßling - Lubrizol Corporation
Teamleiter Qualitätssicherung(m/w/x)
Full-timeOn-siteSeniorWeßling - EOS GmbH Electro Optical Systems
Supplier Quality Engineer(m/w/x)
Full-timeTemporary contractOn-siteExperiencedKrailling - Bavarian Nordic GmbH
Quality Assurance Specialist for Quality Control(m/w/x)
Full-timeOn-siteExperiencedMartinsried - EOS
Qualitätstechniker(m/w/x)
Full-timeOn-siteExperiencedKrailling