Quality Engineer 3
MILLENNIUMSOFT
Roles & Responsibilities
- Apply quality engineering principles, theories, and tools (acceptance sampling, statistical process control, measurement systems analysis, failure analysis, design of experiments, process mapping, hypothesis testing, process capability analysis, basic quality tools, risk management, etc.)
- Represent Quality as a team member on sustaining engineering projects
- Write, review, and approve protocols, reports, and data analyses
- Ensure design control and production/process control projects meet applicable regulatory, corporate, and unit requirements
- Review and approve new/modified design and process specifications, including product performance specs and test methods
- Influence and/or direct others across organization and cross-functional teams
- Support material change and IFU revision projects across a range of products
- 4 to 10 years of relevant experience (5- 6 years preferred)
- Minimum of 5 years relevant experience in medical device or equivalent regulated industry required
- Process validation experience (IQ/OQ/PQ) preferred
- Supervisory or project management experience a plus
- Basic statistical analysis skills for interpreting test data (Minitab preferred)
- Design Transfer and Design Control principles
- ISO 14971 Risk Management and risk management activities
- Strong problem-solving skills
- Oral and written communication skills
- Ability to work in cross-functional teams
- Bachelor's degree required (Science, Technology, Engineering, or Math preferred)
- Experience in the medical device or equivalent regulated industry required
- Working knowledge of design controls, design verification/validation, and CAPA (Corrective and Preventive Action)
- Onsite presence required 4 days/week; 1 day remote
- No drug screening required for this assignment
Vacancy posted 4 days ago
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