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Analyst II Quality Assurance - Job Opportunity at Beckman Coulter Diagnostics

Marseille, FR
Full-time
Mid-level
Posted: August 21, 2025
On-site
EUR 45,000 - 55,000 annually based on the mid-level experience requirements, specialized regulatory knowledge in medical devices, and Marseille market conditions. The international scope and Danaher affiliation typically command premium compensation in the French market.

Benefits

International work environment exposure providing global career development opportunities and cross-cultural collaboration experience
Opportunity to work with cutting-edge diagnostic technology and innovative biomedical testing solutions
Professional development through Danaher Business System tools and continuous improvement methodologies
Involvement in critical healthcare solutions that directly impact patient care and medical research worldwide
Access to comprehensive quality management systems and regulatory compliance training

Key Responsibilities

Serve as the primary quality assurance representative for the Blood Virus Program, ensuring strategic alignment with regulatory requirements and company standards
Execute comprehensive design control reviews at each development phase, maintaining compliance integrity and ensuring proper closure of Design History Files for regulatory submissions
Lead the approval process for characterization reports and verification protocols, directly impacting product launch timelines and market readiness
Assess and approve design changes while evaluating their strategic impact on Device Master Records and regulatory documentation
Drive continuous improvement initiatives using Danaher Business System methodologies, contributing to operational excellence and cost reduction
Represent the quality function in internal and external audits, safeguarding company reputation and regulatory standing
Conduct internal quality audits to ensure QMS compliance, identifying risks and improvement opportunities
Facilitate risk management processes including FMEA sessions, contributing to product safety and reliability

Requirements

Education

Bachelor's degree or Master's degree in chemistry, biochemistry, biology or other relevant technical field

Experience

2 years minimum experience in a highly regulated (FDA desirable) healthcare or related environment

Required Skills

Excellent interpersonal / communication skills Strong team member with the ability to identify and drive quality improvements Excellent planning and organizational skills Fluent level of French and English (written and spoken) Good listening skills, analytical and synthesis capabilities Good adaptation capacity
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Sauge AI Market Intelligence

Industry Trends

The in-vitro diagnostics (IVD) market is experiencing unprecedented growth driven by aging populations, increased disease prevalence, and the ongoing emphasis on early detection and personalized medicine. The COVID-19 pandemic has accelerated automation and digitalization in laboratory testing, creating sustained demand for sophisticated diagnostic platforms. Regulatory harmonization across global markets is driving the need for quality professionals who understand multiple regulatory frameworks, particularly FDA and European MDR requirements. Medical device companies are increasingly investing in infectious disease testing capabilities, with immunoassay development becoming a critical competitive differentiator. The shift toward point-of-care testing and decentralized diagnostics is creating new quality assurance challenges, requiring professionals who can navigate complex regulatory pathways while ensuring product safety and efficacy. Consolidation in the diagnostics industry through mergers and acquisitions is creating larger, more complex organizations that require robust quality management systems. Companies like Beckman Coulter, operating under Danaher Corporation, are leveraging operational excellence methodologies to drive efficiency and maintain competitive advantage in a rapidly evolving market.

Role Significance

Typically operates within a quality team of 5-8 professionals, collaborating closely with R&D teams of 15-25 engineers and scientists, while interfacing with regulatory affairs, manufacturing, and clinical teams across multiple geographic locations.
This is a mid-level specialist position with significant autonomy in quality decision-making and cross-functional influence. The role carries substantial responsibility for regulatory compliance and product approval processes, indicating trusted expertise within the organization. The international scope and audit representation responsibilities suggest this position is viewed as a subject matter expert role.

Key Projects

Leading quality reviews for new immunoassay product launches with multi-million euro revenue potential Managing regulatory submission documentation for FDA 510(k) and European CE marking processes Implementing design control improvements that reduce development cycle times and compliance risks Supporting manufacturing transfer activities for new diagnostic platforms entering global markets

Success Factors

Mastery of medical device regulatory frameworks, particularly FDA QSR and ISO 13485, combined with deep understanding of design control processes and risk management methodologies. Success requires the ability to balance regulatory compliance with business objectives while maintaining product development timelines. Strong cross-functional collaboration skills to influence technical decisions without direct authority, requiring diplomatic communication and the ability to translate regulatory requirements into actionable engineering and business guidance. Cultural sensitivity and multilingual capabilities are essential for success in the international environment. Strategic thinking capability to anticipate regulatory changes and their impact on product development, combined with practical problem-solving skills to resolve complex compliance issues. Success demands both attention to detail for documentation review and big-picture thinking for process improvement initiatives.

Market Demand

High demand driven by regulatory complexity in medical devices, shortage of experienced quality professionals in IVD sector, and continued growth in diagnostic testing markets globally.

Important Skills

Critical Skills

Regulatory compliance expertise in medical device quality systems is absolutely essential as this role directly impacts product approvals and market access. Deep knowledge of FDA QSR, ISO 13485, and European MDR requirements forms the foundation of success, as regulatory missteps can result in significant financial and reputational consequences for the organization. Design control proficiency is critical for managing the complex development processes of diagnostic products, requiring understanding of verification and validation principles, risk management, and design history file management. This expertise directly influences product development timelines and regulatory submission success rates. Cross-functional communication and influence skills are vital for success in this matrixed organization where quality professionals must drive compliance without direct authority over technical teams. The ability to build consensus and influence decision-making across diverse stakeholders is essential for achieving quality objectives.

Beneficial Skills

Project management capabilities and familiarity with lean methodologies would enhance effectiveness in driving improvement initiatives and managing complex regulatory projects with multiple stakeholders and tight deadlines Clinical research understanding and biostatistics knowledge would provide valuable context for interpreting validation data and supporting clinical evidence requirements for regulatory submissions Digital quality management system experience with platforms like Veeva Vault or MasterControl would be advantageous as the industry continues to digitize quality processes and documentation management

Unique Aspects

This role offers exposure to cutting-edge infectious disease diagnostics development during a period of unprecedented market growth and regulatory focus, providing invaluable experience in pandemic preparedness and public health applications
The international scope within Danaher's global network provides unique opportunities for cross-border collaboration and exposure to multiple regulatory frameworks, enhancing career portability and expertise
Direct involvement in blood virus testing program development offers specialized expertise in a high-growth, high-impact therapeutic area with significant clinical and commercial importance
Integration with Danaher Business System methodologies provides world-class training in operational excellence and continuous improvement, highly valued across the life sciences industry

Career Growth

Career progression typically follows 2-3 year advancement cycles in the medical device industry, with opportunities for accelerated growth based on regulatory expertise and cross-functional leadership capabilities.

Potential Next Roles

Senior Quality Assurance Specialist or Principal QA Scientist within 2-3 years, focusing on more complex therapeutic areas or leading quality initiatives across multiple product lines Quality Assurance Manager or Team Lead positions within 3-5 years, managing quality teams and budgets while interfacing directly with regulatory agencies Regulatory Affairs Manager or Director roles within 5-7 years, transitioning to strategic regulatory planning and agency relationship management Quality Director or VP Quality positions within 7-10 years, overseeing enterprise-wide quality systems and compliance strategies

Company Overview

Beckman Coulter Diagnostics

Beckman Coulter Diagnostics operates as a leading global player in the in-vitro diagnostics market under Danaher Corporation's Life Sciences division. The company has established itself as a technology innovator in laboratory automation, immunoassay development, and clinical chemistry solutions, serving hospitals, reference laboratories, and research institutions worldwide. With a strong focus on infectious disease testing and hematology diagnostics, the company maintains significant market share in key therapeutic areas.

Positioned among the top five global IVD companies with annual revenues exceeding $3 billion, competing directly with Abbott, Roche Diagnostics, and Siemens Healthineers. The company's strength lies in laboratory automation and high-throughput testing solutions, with particular leadership in immunochemistry and hematology markets.
The Marseille site serves as a key European development and manufacturing hub, supporting global product launches and regulatory submissions. This location plays a strategic role in the company's European market penetration and serves as a center of excellence for immunoassay development, with strong connections to regional academic and clinical research networks.
Danaher's renowned business system emphasizes continuous improvement, operational excellence, and scientific rigor, creating a performance-driven environment that values innovation and quality. The culture promotes cross-functional collaboration and global teamwork, with significant investment in employee development and career advancement opportunities.
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