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About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Medical
- Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurance engineeringCorrective and Preventive Action (CAPA)Material Review Boardsroot cause analysisGage R&RAnalysis of VarianceFailure Modes and Effects AnalysisStatistical Process Controlacceptance samplingexperimental design
Soft Skills
customer servicecommunicationproblem solvingdecision makingleadershipcross-functional collaborationprioritizationtime managementattention to detailadaptability