Salary
💰 $115,440 - $173,160 per year
About the role
- Manage the quality and compliance for applicable products and processes
- Ensure quality and regulatory compliance with applicable regulations
- Act as a liaison with Divisions, Suppliers, Manufacturing, and/or Operations
- Manage complaints and develop new approaches to solve problems
- Identify and manage the execution of continuous improvement projects
- Assist in the planning of design, testing, inspection, and process validations
- Ensure all quality issues are resolved to customer satisfaction in a timely manner
Requirements
- Bachelor’s degree in Engineering, Science, or Technical Field
- At least 4 years of experience related to the design/operation of medical device or drug combination product platforms
- Knowledge of QSR/GMP/ISO requirements or other regulated industries
- Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR)
- Proficiency in analyzing and reporting data
- Advanced level skill in Microsoft Excel
- Position requires travel up to 25% of the time for business purposes
- health insurance
- life and disability
- 401(k) contributions
- paid time off
- continuing education & training
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analysisproblem solvingcontinuous improvementdesign validationtestinginspectionprocess validationregulatory compliancequality managementcomplaint management
Soft skills
communicationliaisoncustomer satisfactionproject managementteam collaboration