Senior Quality Engineer
At Microline, we are on a mission to improve the quality of life for everyone. To do that, we seek the best talent to expand and improve our team of dedicated, innovative employees.Apply for Position
The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.
Summary: Maintain the quality system and support outgoing product quality through the use of engineering tools and methodologies in order to support 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.
- Maintain Quality Records.
- Perform Corrective Actions and Non-conformance assessments.
- Assist in investigating customer complaints.
- Perform internal audits as well as supplier audits.
- Support Incoming Inspection.
- 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.
- Identify and prioritize continual improvement ideas.
In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.
- Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent experience;
- advanced degree is preferred
- Very good written and verbal communication skills.
- ·At least 8 years of engineering experience; preferably in the medical device industry.
- Experience leading continual improvement projects.
- CQE/CQA certification helpful but not required.
- Certified biomedical auditor is preferred.
- Familiar with FDA 21CFR820, ISO13485.
- Experience with aseptic production and/or sterilization is preferred.
- Accuracy, thoroughness, attention to detail, legibility in completing records is essential.·
- Project management training or certification is a plus.
- Lean and 6Sigma knowledge a plus.
REASONABLE ACCOMMODATION: Microline is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.Apply for Position