Senior Quality Director

Vor 4 Tagen


Stuttgart, Baden-Württemberg, Deutschland EPM Scientific Vollzeit

About the Role:

The Senior Quality Director will oversee the entire quality management system (QMS) for EPM Scientific's medical device manufacturing operations in Germany. This role ensures that all products meet the highest standards of quality and compliance with regulatory requirements.

Key Responsibilities:

Leadership and Strategy:

  • Develop and implement a strategic quality plan aligned with company objectives.
  • Lead and mentor the quality team, fostering a culture of quality and compliance.

Quality Management System:

  • Oversee the development, implementation, and maintenance of the QMS in accordance with ISO 13485, FDA regulations, and other relevant standards.

Regulatory Compliance:

  • Ensure compliance with all relevant medical device regulations and standards, including EU MDR, FDA 21 CFR Part 820, and others.

Quality Assurance and Control:

  • Oversee product quality assurance and control activities, including incoming material inspections, in-process inspections, and final product testing.
  • Develop and monitor key quality metrics, and implement corrective and preventive actions (CAPA) to address any issues.

Supplier Quality Management:

  • Establish and maintain a robust supplier quality management program.
  • Conduct supplier audits and assessments to ensure compliance with quality standards.
  • Collaborate with suppliers to resolve quality issues and improve their processes.

Risk Management:

  • Lead the risk management process for all products, including risk assessments and mitigation strategies.
  • Ensure effective post-market surveillance and feedback mechanisms are in place to monitor product performance and address any issues promptly.

Qualifications:

  • Bachelor's or Master's degree in Engineering, Quality Management, or a related field.
  • Minimum of 8 years of experience in quality management, with at least 5 years in a senior leadership role within the medical device industry.
  • In-depth knowledge of ISO 13485, EU MDR, FDA regulations, and other relevant standards.
  • Proven track record in leading and developing high-performing quality teams.
  • Strong analytical and problem-solving skills, with a focus on continuous improvement.
  • Excellent communication and interpersonal skills, with the ability to influence at all levels of the organization.
  • Fluency in English and German.


  • Stuttgart, Baden-Württemberg, Deutschland BioTalent Vollzeit

    Global Quality OpportunityBioTalent is currently supporting a leading global partner in the pharmaceutical and healthcare industries. They are seeking a Quality Director to drive the global growth and quality vision where you will lead quality managers in Europe and Asia, and enhance the quality strategy and culture.Key Responsibilities:Lead and develop...


  • Stuttgart, Baden-Württemberg, Deutschland BioTalent Vollzeit

    Global Quality OpportunityBioTalent is currently supporting a leading global partner in the pharmaceutical and healthcare industries. They are seeking a Quality Director to drive the global growth and quality vision where you will lead quality managers in Europe and Asia, and enhance the quality strategy and culture.Key Responsibilities:Lead and develop...


  • Stuttgart, Baden-Württemberg, Deutschland BioTalent Vollzeit

    Global Quality OpportunityBioTalent is currently supporting a leading global partner in the pharmaceutical and healthcare industries. They are seeking a Quality Director to drive the global growth and quality vision where you will lead quality managers in Europe and Asia, and enhance the quality strategy and culture.Key Responsibilities:Lead and develop...


  • Stuttgart, Baden-Württemberg, Deutschland BioTalent Vollzeit

    Global Quality OpportunityBioTalent is currently supporting a leading global partner in the pharmaceutical and healthcare industries. They are seeking a Quality Director to drive the global growth and quality vision where you will lead quality managers in Europe and Asia, and enhance the quality strategy and culture.Key Responsibilities:Lead and develop...


  • Stuttgart, Baden-Württemberg, Deutschland Pharmiweb Vollzeit

    Job Title: Senior Medical Director - OncologyTasks & responsibilitiesIn this role, you represent Medicine at the International Multidisciplinary Evidence Teams and you take clinical development responsibility for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, core Clinical Trial...


  • Stuttgart, Baden-Württemberg, Deutschland LässingMüller Vollzeit

    Über unsLässingMüller ist eine etablierte und bedeutende Agentur in Stuttgart, die sich auf ganzheitliche und kanalübergreifende Kommunikation spezialisiert hat. Wir arbeiten für Konzernkunden und den Mittelstand in verschiedenen Branchen, wie Getränke, Medizintechnik, Industrie, Energieversorger und Elektrowerkzeuge.Deine AufgabenAls Senior Art...


  • Stuttgart, Baden-Württemberg, Deutschland LässingMüller Vollzeit

    Über unsLässingMüller ist eine etablierte und bedeutende Agentur in Stuttgart, die sich auf ganzheitliche und kanalübergreifende Kommunikation spezialisiert hat. Wir arbeiten für Konzernkunden und den Mittelstand in verschiedenen Branchen, wie Getränke, Medizintechnik, Industrie, Energieversorger und Elektrowerkzeuge.Deine AufgabenAls Senior Art...

  • Senior Legal Director

    vor 1 Woche


    Stuttgart, Baden-Württemberg, Deutschland Central Parking Vollzeit

    About the RoleWe are seeking a highly experienced and skilled Senior Legal Director to join our team at Central Parking. As a key member of our leadership team, you will play a critical role in shaping the company's legal strategy and ensuring compliance with all relevant laws and regulations.Key ResponsibilitiesLead on Key Business Initiatives: Take the...

  • Senior Legal Director

    Vor 6 Tagen


    Stuttgart, Baden-Württemberg, Deutschland Central Parking Vollzeit

    About the RoleWe are seeking a highly experienced and skilled Senior Legal Director to join our team at Central Parking. As a key member of our leadership team, you will play a critical role in shaping the company's legal strategy and ensuring compliance with all relevant laws and regulations.Key ResponsibilitiesLead on Key Business Initiatives: Take the...

  • Senior Legal Director

    Vor 2 Tagen


    Stuttgart, Baden-Württemberg, Deutschland Central Parking Vollzeit

    About the RoleWe are seeking a highly experienced and skilled Senior Legal Director to join our team at Central Parking. As a key member of our leadership team, you will play a critical role in shaping the company's legal strategy and ensuring compliance with all relevant laws and regulations.Key ResponsibilitiesLead on Key Business Initiatives: Take the...

  • Senior Legal Director

    Vor 2 Tagen


    Stuttgart, Baden-Württemberg, Deutschland Central Parking Vollzeit

    About the RoleWe are seeking a highly experienced and skilled Senior Legal Director to join our team at Central Parking. As a key member of our leadership team, you will play a critical role in shaping the company's legal strategy and ensuring compliance with all relevant laws and regulations.Key ResponsibilitiesLead on Key Business Initiatives: Take the...


  • Stuttgart, Baden-Württemberg, Deutschland P3 Vollzeit

    About P3P3 is a leading consulting firm that prides itself on its unique approach to business. Our team members are characterized by their curiosity, sense of adventure, and passion for innovation.Our ApproachWe empower our consultants to take on early responsibility for our clients in the areas of management consulting, technology, and scalable IT...


  • Stuttgart, Baden-Württemberg, Deutschland P3 Vollzeit

    About P3P3 is a leading consulting firm that prides itself on its unique approach to business. Our team members are characterized by their curiosity, sense of adventure, and passion for innovation.Our ApproachWe empower our consultants to take on early responsibility for our clients in the areas of management consulting, technology, and scalable IT...

  • Senior Legal Director

    Vor 6 Tagen


    Stuttgart, Baden-Württemberg, Deutschland Central Parking Vollzeit

    About the RoleWe are seeking a highly experienced and skilled Senior Legal Director to join our team at Central Parking. As a key member of our leadership team, you will play a critical role in shaping the company's legal strategy and ensuring compliance with all relevant laws and regulations.Key ResponsibilitiesLead on Key Business Initiatives: Take the...

  • Senior Legal Director

    vor 2 Wochen


    Stuttgart, Baden-Württemberg, Deutschland Central Parking Vollzeit

    About the RoleWe are seeking a highly experienced and skilled Senior Legal Director to join our team at Central Parking. As a key member of our leadership team, you will play a critical role in shaping the company's legal strategy and ensuring compliance with all relevant laws and regulations.Key ResponsibilitiesLead on Key Business Initiatives: Take the...


  • Stuttgart, Baden-Württemberg, Deutschland Exyte Vollzeit

    Job SummaryExyte is seeking a highly experienced Senior Director, Procurement and Subcontracting to lead our procurement and subcontracting efforts in Continental Europe and Northern Europe and Israel. As a key member of our regional leadership team, you will be responsible for developing and deploying a regional procurement and subcontracting strategy to...


  • Stuttgart, Baden-Württemberg, Deutschland Exyte Vollzeit

    Job SummaryExyte is seeking a highly experienced Senior Director, Procurement and Subcontracting to lead our procurement and subcontracting efforts in Continental Europe and Northern Europe and Israel. As a key member of our regional leadership team, you will be responsible for developing and deploying a regional procurement and subcontracting strategy to...


  • Stuttgart, Baden-Württemberg, Deutschland Humres - Construction Recruitment Specialists Vollzeit

    Job OverviewHumres - Construction Recruitment Specialists is seeking a highly skilled and motivated Senior Quality Assurance Manager to lead their Quality Control Department at their specialized Lightweight Structures and Facades Engineering Company. The ideal candidate will have extensive experience in quality assurance and control processes within the...


  • Stuttgart, Baden-Württemberg, Deutschland Humres - Construction Recruitment Specialists Vollzeit

    Job OverviewHumres - Construction Recruitment Specialists is seeking a highly skilled and motivated Senior Quality Assurance Manager to lead their Quality Control Department at their specialized Lightweight Structures and Facades Engineering Company. The ideal candidate will have extensive experience in quality assurance and control processes within the...


  • Stuttgart, Baden-Württemberg, Deutschland Exyte Vollzeit

    Lead Procurement and Subcontracting for ExyteAs a Senior Director, Procurement and Subcontracting, you will be responsible for developing and deploying a regional procurement and subcontracting strategy to support the achievement of business goals and objectives. This role is part of Exyte's regional leadership team and leads strategically and operationally...