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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance with a focus on Supplier Management, including the development and execution of qualification programs, risk assessment, and compliance with Good Manufacturing Practices. Proficient in technical writing, data analysis, and leading cross-functional teams to drive supplier quality improvements.
Highest-signal resume keywords
Quality AssuranceSupplier ManagementInjection MoldingTechnical WritingGood Manufacturing Practices
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceSupplier ManagementInjection MoldingTechnical WritingTrend AnalysisStatistical AnalysisProject ManagementMaterial SpecificationsSupplier AuditsQuality System Metrics
Soft Skills
Attention to DetailOrganizational SkillsCollaborationMentoringPresentation Skills
Tools & Technologies
Electronic Document Management SystemSAPMicrosoft Office Suite
Industry Keywords
Good Manufacturing PracticesSupplier QualificationRoot-Cause AnalysisNonconformanceVendor NotificationCross-Functional TeamsFDA Audits
About the role
Key responsibilities & impact- Serve as primary quality lead on cross-functional teams focused on new materials, supplier qualification and supplier changes
- Develop and update material specifications and ensure specifications are created and approved
- Apply a risk-based approach to create and execute the annual supplier audit program
- Develop and execute qualification programs for new materials and suppliers
- Define and monitor supplier risk levels
- Provide rationale for supplier status event reports and ensure actions are completed on time
- Establish Vendor Notification processes and maintain communication of supplier nonconformances (SCAR)
- Lead investigations, root-cause analysis and corrective and preventive actions for supplier issues
- Review, approve and monitor Supplier Qualification and Performance scorecards
- Assess and approve supplier quality documentation and improvement plans
- Develop and trend Supplier Quality System metrics
- Create, review and approve supplier quality procedures and documentation
- Assess quality agreements with suppliers
- Conduct and approve internal and external audits and finalize audit reports
- Author and technically assess raw-material specifications
- Lead critical-issue and stakeholder meetings, document minutes and follow up on actions
- Assess and approve supplier change notifications and monitor implementation
- Apply knowledge of plastics and injection molding to support qualification, assess manufacturing capabilities and troubleshoot quality issues
- Assess injection molding processes, materials, tooling and supplier controls
- Support quality-system and procedural training programs
- Host third-party audits from the FDA, notified bodies and business
Requirements
What you’ll need- Minimum Bachelor's degree in biology, chemistry, biochemistry, biomedical engineering or related field
- Minimum of 8 years of relatable work experience in Quality Assurance
- 5-year prior experience in Supplier Management
- Experience with injection molding and plastics
- Prior experience working with an electronic document management system is required
- Technical writing, trend analysis and lead projects experience is preferred
- Experience implementing changes, trend analysis and improvements is a plus
- Prior experience working with SAP is a plus
- Excellent writing and technical writing skills
- Excellent presentation skills
- Knowledge of materials, formulation and manufacturing processes
- Proficient in Microsoft Office Suite
- Knowledge and proof of experience of Good Manufacturing Practice processes and procedures
- Strong attention to detail and ability to analyze data using statistical software
- Strong project management and organizational skills
- Ability to train and mentor
- Ability to work collaboratively with cross-functional teams
- Ability to occasionally travel within the United States
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical
- Dental
- Vision
- PTO
- Up to 5% 401(K) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
- Family-like culture