Key Customer Contact Quality Engineer providing quality assurance support for medical devices at Solventum. Collaborating with innovative teams to address quality concerns and improve customer satisfaction.
Responsibilities
Providing quality assurance engineering support for commercial components (sold to medical device and combination product manufacturers).
Serving as the key account customer contact for the MedTech OEM quality engineering team.
Ensuring key account customer projects and issues are prioritized across functions and executed expeditiously.
Providing exceptional customer service for complaints, related investigations, completion of customer questionnaires, and hosting customer audits.
Working with sales and business partners, communicating clearly and accurately while managing customer expectations related to quality concerns.
Managing the creation and execution of specific key account customer Quality Agreements, ensuring compliance to agreed upon terms and conditions
Assuring compliance with internal Standard Operating Procedures (SOPs) and external regulations.
Leading Corrective and Preventive Action (CAPA) and Material Review Boards for customer-impacting issues.
Requirements
Bachelor’s Degree or higher AND five (5) years of experience in combined product, quality, engineering, and/or laboratory/research & development experience in a private, public, government or military environment OR High School Diploma/GED AND nine (9) years of experience in combined product, quality, engineering, and/or laboratory/research & development experience in a private, public, government or military environment
Five (5) years of experience in customer-facing product, quality, engineering, and/or laboratory/research & development experience in a private, public, government or military environment
Experience supporting customers, including the investigation, resolution, and closure of customer quality issues
Experience producing clear, concise, and fact-based written and verbal communications for customers and cross-functional stakeholders (e.g., reports, presentations, technical documentation, or formal correspondence)
Experience making decisions and solving problems using structured approaches (e.g., root cause analysis, prioritization frameworks, or continuous improvement methodologies) to deliver results within defined timelines while managing competing priorities
Experience leading or influencing work activities, initiatives, or projects by identifying improvement opportunities, coordinating with cross-functional teams, and driving changes from planning through execution
Experience working in an FDA-regulated medical device, combination product, or pharmaceutical environment, including familiarity with applicable quality system and regulatory requirements
Experience in the use of statistical and quality engineering tools such as basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability, acceptance sampling, correlation and regression, and experimental design
Benefits
Medical
Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
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