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Global Supplier Quality Engineer - Plastics - Job Opportunity at Beckman Coulter Diagnostics

Isernhagen, Germany
Full-time
Senior
Posted: July 3, 2025
Hybrid
EUR 75,000 - 95,000 annually based on senior-level responsibilities, German market conditions, international scope, and specialized medical device industry requirements

Benefits

Comprehensive career development program with meaningful advancement opportunities in a well-established diagnostics company with 80+ years of market presence
Inclusive workplace culture that actively celebrates diverse backgrounds, experiences, and perspectives of all associates
Creative freedom and innovation support with organizational backing to try new approaches and implement strategic initiatives
Global collaboration opportunities working alongside six fellow Diagnostics Companies within the Danaher ecosystem
Flexible location options including remote work possibilities for qualified candidates across multiple strategic office locations

Key Responsibilities

Lead strategic supplier quality initiatives aligned with global commodity sourcing objectives, directly impacting manufacturing efficiency and cost optimization across international operations
Drive comprehensive supplier development programs through quality workshops and process capability improvements, establishing long-term partnerships that enhance product reliability and operational performance
Execute critical supplier audits, qualifications, and performance assessments ensuring compliance with internal quality standards, customer requirements, and regulatory frameworks while maintaining supply chain continuity
Serve as strategic quality leader throughout the complete supplier lifecycle from initial selection through contract negotiations to ongoing relationship management, directly influencing business outcomes and risk mitigation strategies
Collaborate with cross-functional teams across R&D, Procurement, Operations, Quality, and Regulatory Affairs to embed quality excellence into all product lifecycle phases, driving year-over-year improvements in supplier performance metrics

Requirements

Education

Bachelor's degree in technical field with 9+ years' experience or master's degree in field with 7+ years' experience or comparable

Experience

Minimum 5 years of experience in supplier quality engineering or supplier development within international manufacturing environments

Required Skills

Deep expertise in quality systems and tools, including risk management, CAPA, APQP, PPAP, FAI, and statistical analysis methodologies Exceptional communication and interpersonal skills, with a proven ability to influence cross-functional teams and external suppliers Ability and willingness to travel up to 25%, based on business needs

Certifications

CQE, CQA, Six Sigma, or equivalent (preferred) Experience in FDA-regulated or medical device manufacturing environments (preferred) Familiarity with ISO13485, 21 CFR Part 820, and other relevant regulatory frameworks (preferred)
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Sauge AI Market Intelligence

Industry Trends

The medical diagnostics industry is experiencing unprecedented growth driven by aging populations, increased health awareness, and technological advancement in precision medicine, creating strong demand for quality engineers who can ensure regulatory compliance and operational excellence Supply chain resilience has become critical following global disruptions, with companies investing heavily in supplier quality management and risk mitigation strategies, particularly for specialized materials like medical-grade plastics Digital transformation in manufacturing is driving demand for quality engineers who can implement data-driven approaches and statistical analysis methodologies to optimize supplier performance and predictive quality management Regulatory requirements in medical device manufacturing continue to intensify globally, creating premium demand for professionals with expertise in FDA regulations, ISO13485, and international quality standards

Role Significance

Typically manages relationships with 15-25 key suppliers while collaborating with cross-functional teams of 8-12 professionals including operational SQEs, commodity managers, and regulatory affairs specialists
Senior-level position with significant strategic impact, serving as a global quality liaison with direct influence on supplier relationships, risk management, and business continuity across international operations

Key Projects

Implementation of comprehensive supplier qualification programs for new plastic materials and manufacturing processes Development of global quality standards and audit protocols for international supplier network Risk assessment and mitigation planning for critical supply chain vulnerabilities Cross-functional product lifecycle quality integration from R&D through commercialization

Success Factors

Deep understanding of medical device regulatory landscape combined with practical application of quality systems in international manufacturing environments Strong relationship management and influence skills to drive supplier performance improvements without direct authority over external organizations Data-driven analytical approach to identify quality trends, predict risks, and implement preventive measures across global supplier network Strategic thinking ability to align quality initiatives with business objectives while balancing cost, quality, and delivery requirements

Market Demand

High demand driven by critical importance of quality assurance in medical device manufacturing, limited pool of candidates with combined plastics expertise and regulatory knowledge, and industry growth in diagnostics sector

Important Skills

Critical Skills

Quality systems expertise including CAPA, APQP, and statistical analysis is fundamental to success in this role, as these methodologies form the backbone of supplier development and risk management in regulated manufacturing environments Cross-functional collaboration and influence skills are essential given the need to work effectively with suppliers, internal teams, and stakeholders across different cultures and organizational structures without direct authority Regulatory knowledge of FDA and ISO standards is critical for ensuring compliance and managing risk in medical device manufacturing where quality failures can have serious patient safety implications

Beneficial Skills

Six Sigma certification and lean manufacturing knowledge provide additional value in driving process improvements and cost optimization initiatives International business experience and cultural awareness enhance effectiveness in global supplier relationship management Project management skills and change management capabilities support large-scale quality improvement initiatives across multiple locations and organizations

Unique Aspects

Specialized focus on plastics within medical device manufacturing, requiring unique combination of materials science knowledge and regulatory expertise
Global scope with significant international travel and cross-cultural collaboration opportunities
Strategic role within Danaher ecosystem providing exposure to best practices across multiple diagnostics companies
Direct impact on patient outcomes through quality assurance in critical diagnostic equipment manufacturing

Career Growth

Advancement to director level typically occurs within 3-5 years with strong performance, while C-suite progression requires 7-10 years of progressive leadership experience

Potential Next Roles

Senior Director of Global Supplier Quality with expanded organizational responsibility Quality Director for Business Unit with full P&L impact Vice President of Supply Chain Quality across multiple product lines Chief Quality Officer for medical device manufacturing organizations

Company Overview

Beckman Coulter Diagnostics

Beckman Coulter Diagnostics is a well-established leader in the medical diagnostics industry with over 80 years of market presence, operating as part of the Danaher Corporation ecosystem which provides significant resources and strategic advantages in global markets

Strong market position as a recognized leader in laboratory diagnostics with global reach and substantial investment in innovation, benefiting from Danaher's operational excellence framework and financial stability
This German-based role supports European operations while maintaining global responsibilities, positioning the candidate at the intersection of European regulatory requirements and worldwide supply chain management
Collaborative environment emphasizing diversity, inclusion, and associate empowerment with strong support for professional development and innovation, backed by resources of a Fortune 500 parent company
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