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About the role
Key responsibilities & impact- Applies knowledge of technical principles and BD systems/procedures to optimize manufacturing and Quality processes
- Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
- Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
- Basic understanding of statistical techniques
- Solid understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering
- Solid problem-solving, organizational, analytical and critical thinking skills
- Solid understanding of processes and equipment used in assigned work
- Knowledge of applicable FDA regulations for medical device industry
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
- Ability to build productive internal/external working relationships
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Requirements
What you’ll need- Bachelor’s degree in Engineering, Computer Science, Health Science or Scientific field
- 2 years’ experience required or; Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education required
- Expertise in extracting, filtering, validating and downloading data from Power BI
- Expertise in manipulating, and analyzing large datasets using advanced excel functions and formulas (VLOOKUP, pivot tables, conditional formulas)
- Expertise in ETQ Quality Management System
- Experience in the post-market surveillance area including review and investigations of complaints
- Experience in regulatory compliance and quality systems: CAPA, FMEA, RMW
- Experience with quality and compliance data
- Experience in Trackwise QMS a plus
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills
- Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
Benefits
Comp & perks- Total Rewards program
- Health insurance
- 401(k) matching
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 EngineeringStatistical techniquesData extractionData filteringData validationData analysisAdvanced Excel functionsETQ Quality Management SystemTrackwise QMSRegulatory compliance
Soft Skills
Problem-solvingOrganizational skillsAnalytical skillsCritical thinkingAttention to detailInterpersonal skillsCommunication skillsTeamworkRelationship buildingTime management