Quality Engineering is a fast paced, dynamic environment requiring decision making at the strategic and tactical levels. The job requires a highly motivated self-starter with an ability to work with minimal supervision in a team environment.
This role will serve as a resource to product development and manufacturing to improve product quality, reliability, and process capability.
You will facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis and root cause analysis tools. You will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability and quality of products.
- Develop and implement reliability analysis, design, validation and assessment methods to support successful new product introductions and or sustaining product changes
- Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
- Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
- Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable
- Work with Engineering and R&D to develop reliability testing plus modeling methods specific to products and systems for HALT, Shock and Vibration, Weibull, MTBF and others as required
- Set Reliability goals for products and their subsystems in the field and measure against progress. Maintain a knowledge base of lessons learned to enable continuous improvement
- Manage and assess reliabilityrisks that could adversely affect operations by providing analysis, diagnostics, and reporting. This will involve data analysis techniques to help companies meet accepted reliability standards.
- Writes detailed Risk Assessments, updates Process Hazard Analysis, and present analysis to the Risk Management Board
- Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
- Bachelor’s degree in Mechanical, Electrical, ReliabilityEngineering, or related.
- Minimum 8+ years’ experience in quality assurance field in a regulated environment
- Minimum 6+ years’ experience in medical device industry
- Quality Certification preferred (e.g., CQE)
- Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO14971)
- Results orientation with strong written and oral communications skills to lead cross-functional teams.
- Ability to effectively lead and influence cross functional teams.
- Strong problem identification and problem solving abilities.
Job ID R-17166