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QA Manager Medical Devices - Job Opportunity at Lamm HR GmbH

Frankfurt am Main, Germany
Contract
Senior
Posted: June 25, 2025
On-site
EUR 85,000 - 115,000 annually for permanent positions, though this 4-month contract likely commands EUR 600-800 per day given the specialized expertise required and current market demand for experienced medical device quality professionals in the Frankfurt financial hub.

Benefits

Strategic leadership position in R&D Quality with significant organizational impact and decision-making authority
International collaboration opportunities providing global exposure and cross-cultural professional development
Access to cutting-edge medical device development projects offering continuous learning and innovation exposure
Matrix organizational structure enabling diverse stakeholder engagement and leadership skill development
4-month contract providing focused project experience with potential for extension based on performance

Key Responsibilities

Lead comprehensive Design Control oversight across all R&D project phases, ensuring regulatory compliance and product quality standards that directly impact patient safety and market approval timelines
Drive strategic risk management and usability optimization processes during product development, minimizing regulatory delays and enhancing market competitiveness
Orchestrate regulatory approval processes and clinical study preparation, directly influencing product launch timelines and market entry success
Execute internal and external audit management while ensuring full regulatory compliance, protecting company reputation and maintaining market access
Champion continuous improvement initiatives for R&D quality processes, driving operational excellence and competitive advantage in the medical device market

Requirements

Education

Abgeschlossenes Studium im naturwissenschaftlichen oder technischen Bereich (Bachelor erforderlich, Master wünschenswert)

Experience

Mindestens 8 Jahre Berufserfahrung in der Entwicklung von Medizinprodukten, davon relevante Erfahrung im Bereich Quality

Required Skills

Fundierte Kenntnisse in der Anwendung regulatorischer Anforderungen (MDR, ISO 13485, ISO 14971, 21CFR820 etc.) Kommunikationsstärke Teamgeist Leadership-Kompetenz Sehr gute Englischkenntnisse Sicherer Umgang mit MS Office und QMS-Software

Certifications

ASQ Certified Quality Manager Quality Engineer Auditor
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Sauge AI Market Intelligence

Industry Trends

The medical device industry is experiencing unprecedented regulatory scrutiny following the implementation of the European Medical Device Regulation (MDR), creating high demand for experienced quality professionals who can navigate complex compliance landscapes while maintaining innovation velocity. Aesthetic medical devices represent a rapidly growing segment driven by increasing consumer acceptance and technological advancement, with companies requiring specialized quality expertise to balance cosmetic appeal with rigorous safety standards. Digital transformation in medical device development is driving integration of software-based solutions and connected devices, requiring quality managers to understand both traditional device regulations and emerging digital health requirements. Post-Brexit regulatory fragmentation and evolving international standards are creating demand for quality professionals with multi-jurisdictional expertise who can manage complex global approval processes.

Role Significance

Typically manages or influences 5-15 professionals including quality engineers, regulatory specialists, and project managers, while coordinating with larger R&D teams of 20-50 individuals across multiple concurrent projects.
Senior management position with strategic influence over product development lifecycle, regulatory compliance, and quality systems, requiring independent decision-making and cross-functional leadership in a matrix organization structure.

Key Projects

New product development initiatives requiring full Design Control implementation from concept through market approval Legacy product updates for MDR compliance requiring comprehensive risk assessment and documentation updates Clinical study design and execution for aesthetic device approvals Quality management system optimization and digital transformation initiatives Audit response and CAPA implementation for regulatory compliance maintenance

Success Factors

Deep regulatory expertise across multiple jurisdictions combined with practical implementation experience in fast-paced development environments Strong stakeholder management and influence skills to drive compliance in matrix organizations where authority is shared across functional areas Risk-based thinking and systematic problem-solving abilities to balance innovation speed with regulatory requirements Cultural adaptability and communication skills to work effectively in international teams and with diverse regulatory bodies Change management capabilities to drive continuous improvement while maintaining operational stability

Market Demand

Very high demand driven by regulatory complexity, industry growth, and shortage of experienced professionals with both technical expertise and leadership capabilities in the German medical device sector.

Important Skills

Critical Skills

MDR and ISO 13485 expertise is absolutely essential as these represent the core regulatory framework governing medical device development and commercialization in Europe, with compliance failures resulting in market access denial and significant financial impact Risk management proficiency (ISO 14971) is crucial for patient safety, regulatory approval, and liability management, particularly in aesthetic devices where patient satisfaction and safety must be balanced Leadership and communication skills are vital for success in matrix organizations where influence must be exercised without direct authority, requiring exceptional stakeholder management and change leadership capabilities English proficiency is critical for international collaboration and global regulatory submissions, as most multinational medical device companies operate primarily in English for technical documentation

Beneficial Skills

ASQ certifications provide credibility and systematic methodology for quality management, particularly valuable when working with international teams and regulatory bodies Clinical study experience enhances understanding of evidence generation requirements and regulatory submission strategies Digital quality management system expertise supports operational efficiency and compliance automation Cross-cultural competency enables effective collaboration in international matrix organizations and with diverse regulatory authorities Project management certification would enhance ability to drive complex, multi-stakeholder quality initiatives to successful completion

Unique Aspects

Limited 4-month contract duration suggests either critical project completion, interim leadership during transition, or specialized regulatory submission support, providing intensive experience with potential for permanent opportunity
Focus on aesthetic medical devices offers exposure to unique regulatory pathways combining medical device and cosmetic considerations, valuable expertise in a growing market segment
Matrix organizational structure provides exceptional cross-functional leadership development and stakeholder management experience
International scope with English language requirements indicates global product portfolio and potential for international career development
Combination of R&D focus with quality leadership offers unique perspective on innovation management and commercial product development

Career Growth

Progression to VP-level roles typically occurs within 3-5 years for high-performing senior managers, particularly those with successful track records in complex regulatory environments and international market experience.

Potential Next Roles

VP Quality Assurance or Chief Quality Officer positions overseeing enterprise-wide quality strategy and multiple product portfolios Regulatory Affairs Director roles focusing on global market access and regulatory strategy General Manager or VP R&D positions leveraging quality expertise for broader operational leadership Independent consulting or advisory roles serving multiple medical device companies Executive positions at regulatory bodies or industry associations

Company Overview

Lamm HR GmbH

Lamm HR GmbH operates as a specialized recruitment firm serving the German medical technology and life sciences sectors, indicating this role is with an established medical device manufacturer seeking temporary specialized expertise during critical regulatory or development phases.

The aesthetic medical device sector represents a high-growth, high-margin segment of the medical device industry, with companies typically commanding premium valuations and attracting significant investment for innovation and market expansion.
Frankfurt am Main serves as a major European hub for medical device companies seeking access to both EU markets and international financial resources, providing significant networking and career development opportunities within the life sciences ecosystem.
Matrix organizations in medical device companies typically emphasize collaborative decision-making, scientific rigor, and regulatory precision, while maintaining innovation focus and entrepreneurial energy characteristic of the aesthetic medicine segment.
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