Team Leader Quality Systems & Compliance (m/f/d)

Straumann Group; Basel; On-site; CHF 120,000 - 160,000; Full time

Job summary

Straumann Group in Basel is seeking a Team Leader Quality Systems & Compliance (m/f/d) to steer Document Control & Training across the Group and to act as Global Business Process Owner for these processes. You will ensure regulatory compliance, maintain harmonized QMS processes, and drive continuous improvement, including audits and KPI reporting, in an international matrix setup.

Fluent English is required; a university degree and 5+ years in quality/regulatory roles within medical devices or

Qualifications

• University degree or equivalent in quality, medicine, or related scientific field.
• Minimum 5 years in Quality Management or Regulatory Affairs in medical devices or pharma.
• Experience leading a team and cross-functional collaboration.

Responsibilities

• Lead Document Control & Training across Straumann Group, ensuring compliant document lifecycle and change control.
• Own eQMS governance and ensure regulatory alignment for current and future portfolio.
• Drive global KPIs for Document Control & Training and support audits by authorities.
• Promote harmonized processes and support rollout to new entities across the Group.
• Lead or contribute to continuous improvement and digitalization projects in QMS.

Skills

Team leadership

Quality management

Regulatory affairs

ISO 13485

MDR 2017/745

FDA QMSR (21 CFR Part 820)

Document management

Project management

Digitalization (Power BI, Power Autom​

English proficiency

Education

University degree in quality, medicine, pharmacy, engineering, IT or related field

Tools

Power BI

Power Automate

Generative AI tools

Job description

Are you ready to unlock your potential? At Straumann Group we’re on an exciting journey of growth, innovation, and impact - driven by our mission to improve oral health and transform millions of lives worldwide. United by purpose, we bring our best selves to work every day, embracing a high-performance, player-learner culture that inspires collaboration, curiosity, and ambition. Here, you’ll have the opportunity to take charge of your own career, harnessing your skills, passion, and enthusiasm for learning to continually grow and progress. Together, we’re not just shaping brighter smiles, we’re unlocking the potential of people everywhere, including our own.

As Team Leader Quality Systems & Compliance (m/f/d), you will lead our Document Control & Training team and serve as Global Business Process Owner for Document Control & Training across Straumann Group.

In this role, you will ensure effective governance, regulatory compliance, and continuous improvement of these critical quality processes. Combining people leadership with global process ownership, you will collaborate across functions and Group companies to maintain robust, harmonized, and future-ready quality systems.

You will also act as a subject matter expert during third-party audits, support audit leadership as Front Office or Back Office Lead, contribute to Management Reviews and KPI reporting, and drive quality system improvement and digitalization initiatives.

Your Role

• Lead the Document Control & Training team, responsible for managing applicable QMS documents, regulatory documents, and standards at Straumann Group, Straumann Company, and Design Center Basel levels
• Ensure effective document lifecycle management, controlled distribution, training assignment, and assessment of change adequacy in accordance with applicable procedures
• Ensure QMS training is appropriately assigned, completed, and documented
• Ensure effective implementation and maintenance of the electronic Quality Management System (eQMS) for QMS documentation
• As Global Business Process Owner for Document Control & Training, ensure that eQMS tools and processes meet applicable regulatory requirements and evolve in response to emerging regulations and new product portfolio areas
• Establish and monitor global KPIs for Document Control & Training
• Facilitate regular exchanges among subject matter experts across Group companies to drive improvements, clarify change requests, assess impacts, and share best practices
• Maintain the Group-level Document Control & Training SOP and promote harmonized processes across Group companies
• Support the rollout of Document Control & Training processes to new entities and contribute to eQMS validation activities
• Govern the Straumann Group-level document review process and ensure effective integration of Group-level documents into local Quality Management Systems
• Act as a subject matter expert for your assigned quality process area during third-party audits, including audits by international health authorities
• Serve as Back Office Lead or Front Office Lead, as assigned, supporting the overall Audit Lead in the effective execution of audits
• Lead or contribute to small and medium-sized projects aimed at enhancing the Quality System, including continuous improvement and digitalization initiatives
• Support the preparation and delivery of Management Reviews for Design Center Basel and Straumann Company, collaborating with Business Process Owners to compile the required KPIs

Your Profile

• A university degree or equivalent qualification in quality, medicine, pharmacy, engineering, IT, or another relevant scientific discipline
• At least five years of professional experience in Quality Management or Regulatory Affairs within the medical device or pharmaceutical industry
• Experience leading a team
• Expert knowledge of relevant medical device regulations and standards, particularly ISO 13485, Medical Device Regulation (EU) 2017/745 (MDR), FDA 21 CFR Part 820 Quality Management System Regulation (QMSR), and applicable medical device regulations in MDSAP-participating jurisdictions
• Experience working with document management systems in a regulated environment
• Proven project management experience
• Demonstrated ability to use digitalization such as powerBI, power automation, and generative AI to improve quality management processes
• Fluent written and spoken English, additional languages are welcome

You take a proactive and solution-oriented approach and enjoy collaborating with colleagues and stakeholders across functions and locations. You can balance regulatory requirements with business and process needs and work effectively within an international matrix organization.

You are comfortable navigating change, take ownership of your responsibilities, and look for practical ways to continuously improve how quality processes work. You are also curious about digital technologies and recognize opportunities to use automation and emerging tools to make processes more effective, efficient, and sustainable.

22202