Sr. QA Manager (m/w/d) - Bensheim, Germany

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide.

Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands.

Dentsply Sirona’s products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care.

Dentsply Sirona’s headquarter is located in Charlotte, North Carolina.

The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Visit www. dentsplysirona. com for more information about Dentsply Sirona and its products.

Senior Manager, Quality Assurance EMEA

The Senior Manager, Quality Assurance EMEA is responsible for leading quality management activities across EMEA distribution and commercial operations.

This role ensures compliance with applicable regulatory requirements, including EU MDR, FDA regulations, ISO 13485, and internal quality standards, while driving continuous improvement, risk management, and operational excellence throughout the regional quality organization.

The position provides leadership for regional quality systems, transport quality governance, regulatory inspection readiness, and quality team development while partnering closely with Operations, Supply Chain, Regulatory Affairs, Manufacturing, Service, and Commercial teams.

Key Responsibilities

• Quality Management System Leadership
• Lead quality management activities across EMEA distribution and commercial operations.
• Establish, maintain, and continuously improve the regional Quality Management System (QMS).
• Ensure compliance with applicable regulatory requirements, including EU MDR, FDA 21 CFR Part 820, ISO 13485, and corporate quality standards.
• Drive process harmonization and implementation of global quality initiatives across the regional distribution network.
• Ensure effective management of CAPA, change control, complaint handling, and nonconformance processes.
• Monitor quality system performance through KPIs and quality metrics, identifying trends and improvement opportunities.
• Proactively assess regulatory and operational changes and mitigate associated compliance risks.
• Audit & Regulatory Compliance
• Plan, conduct, and coordinate internal audits and self-assessments.
• Support external audits, regulatory inspections, and third-party assessments.
• Review audit findings and ensure timely implementation of corrective and preventive actions.
• Manage FDA establishment registrations, device listings, and annual renewals.
• Maintain a state of inspection readiness across responsible sites and operations.
• Transport, Distribution & Service Quality
• Provide risk-based oversight of global transportation, distribution, and service quality activities.
• Identify and assess transport quality risks across international transportation lanes.
• Develop and monitor transport quality performance indicators.
• Drive alignment of transportation quality processes, including lane qualification and temperature control strategies.
• Support quality oversight of distribution centers, warehousing operations, logistics providers, and service/repair activities.
• Lead cross-regional continuous improvement initiatives focused on transportation, distribution, and service quality performance.
• Collaborate with regional and global quality stakeholders to ensure consistency across transport and supply chain quality programs.
• Training & Continuous Improvement
• Develop and maintain quality training programs to ensure compliance with regulatory and internal requirements.
• Monitor training effectiveness and employee competency.
• Promote a culture of quality, compliance, accountability, and continuous improvement.
• Lead initiatives to improve quality system efficiency, reduce risk, and strengthen compliance performance.
• Leadership
• Lead, coach, and develop the regional Quality Assurance team.
• Establish performance objectives and support employee development planning.
• Recruit, retain, and develop quality professionals to support business growth.
• Foster collaboration and engagement across the quality organization.
• Partner cross-functionally to address quality issues, reduce deviations, and implement sustainable improvements.

Qualifications

Education

• Bachelor’s degree in Science, Engineering, Life Sciences, Quality, or a related technical discipline required.
• Advanced degree preferred.
• Professional certifications such as ASQ Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), or Six Sigma Green Belt are preferred.
• Critical Experience Requirements
• Medical device industry experience is strongly preferred and represents the ideal background for this role.
• Candidates from the pharmaceutical industry will also be considered, particularly where experience includes operating within highly regulated quality and compliance environments.
• Experience in Distribution Quality, Transportation Quality, and Service & Repair Quality is highly valued and will be considered a significant advantage.
• Proven experience implementing, maintaining, and improving Quality Management Systems in regulated environments.
• Demonstrated experience supporting regulatory inspections, health authority audits, and corporate quality audits.
• Experience collaborating with Regulatory Affairs, Supply Chain, Operations, Manufacturing, and Commercial organizations.
• Previous people leadership experience required.

Experience

• Minimum 10 years of Quality Assurance and/or Regulatory Affairs experience within the medical device and/or pharmaceutical industry.
• Strong experience with Quality Management Systems and regulatory compliance requirements.
• Experience supporting distribution, logistics, warehousing, transportation, and supply chain quality operations.
• Proven track record managing regulatory inspections and quality audits.
• Experience leading cross-functional quality and continuous improvement initiatives in a global environment.

Skills & Competencies

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, MDSAP, MDR, and related regulatory requirements.
• Expertise in CAPA, change control, complaint handling, and nonconformance management.
• Strong understanding of distribution, transportation, logistics, and service quality processes.
• Excellent risk assessment and decision-making capabilities.
• Strong analytical and problem-solving skills.
• Effective project and stakeholder management skills.
• Proven ability to influence and collaborate across functions, sites, and regions.
• Strong communication and leadership skills.
• Results-oriented mindset with a focus on continuous improvement.
• Ability to manage multiple priorities in a dynamic global environment.
• Positive, collaborative, and customer-focused approach.
• Equal
• Opportunity

Employer: Dentsply Sirona is an Equal Opportunity Employer.

All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.

Eligibility: All successful applicants must be eligible to work in the country the position is based.

Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to accommodationrequest@dentsplysirona. com.

Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.

• Notice on
• Fraudulent
• Job

Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities.

If you think a fraudulent source is offering you a job, please have a look at the following information: careers. dentsplysirona. com.

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