Senior Quality Assurance Design Engineer
4 weeks ago
InnoTech Staffing is seeking a Senior Quality Assurance Design Engineer to join their team. This role will be responsible for supporting the design and development of new and improved products in the medical device industry.
Key Responsibilities:- Lead and support the design and development of new or improved products
- Support Design Reviews, Technical Reviews, and Gate Reviews
- Lead and support the execution of all Risk Management and Usability Engineering process activities
- Author or review for approval other Risk Management Documentation
- Support external partners in the development of products
- Coordinate, review and approve development documentation created by external partners
- Develop Reliability models for predicting product performance over time
- Lead implementation of SPC programs with Manufacturing and Quality Control
- Maintains knowledge of and applies statistical analysis to support data-driven decision making
- Work with project teams to develop DOEs and statistically sound tests for appropriate support of results
- Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary
- Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert
- Authoring & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR
- Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
- Identify and implement opportunities for continuous improvement in the quality system
- Interact and coordinate activities with other departments, external vendors, and customers
- Bachelor's degree in Science, Engineering (Biomedical or Mechanical) or related discipline with 4+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing
- Or, Master's degree with 3+ years of experience or equivalent education with years of experience
- Or, Doctoral degree with 1+ years of experience or equivalent education and years of experience
- Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
- Demonstrates excellent organizational, verbal and written communication skills
- Proficient with the MS Office Suite, and statistical software
- Must be able to work independently with minimal supervision
- Able to prioritize projects and manage time to meet organizational goals and objectives
- Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA)
- Knowledge of TrackWise preferred
- Knowledge of Agile product lifecycle management system preferred
- Demonstrated knowledge and understanding of applicable national and international regulations and standards for Design Controls
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