This is an opportunity to join a leading surgical manufacturing company to help maintain the quality system.
You will support ongoing product quality outgoing product quality through the use of engineering tools and methodologies in order to contribute to production, design, and development of medical devices.
- Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
- Make effective use of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE to solve quality problems and mitigate product and process risks.
- Make use of Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D and other problem solving techniques.
- Approve Engineering Change Orders, review prints and be familiar with Geometric Tolerancing.
- Perform Corrective Actions and Non-conformance assessments.
- Perform internal audits as well as supplier audits.
- Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends.
- Participate in and lead continual improvement projects
- Support environmental and sterilization monitoring
- Travel for supplier and R&D support
- Mentor other members of the quality assurance team in statistical and problem solving techniques.
- Execute cross functional projects using project management methodologies such as critical path methodology, critical chain.
- Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent experience; advanced degree is preferred
- At least 8 years of quality engineering experience.
- Experience working in a production environment
- Proficiency with basic statistics (mean, standard deviation, etc.).
- Experience working in medical device or another regulated industry.
- Ability to apply statistical tools to quality problems.