POSTED 01/13/2023
Quality Engineer
Location: Roseville, MN
Quality Engineer
Roseville, MN
Currently looking for a skilled individual to fill a Direct Hire Quality Engineer opening with a company in Roseville, MN. Interested candidates should have a bachelor’s degree plus 5 years of quality experience, with methodical problem-solving skills.
Quality Engineer Job Description:
Roseville, MN
Currently looking for a skilled individual to fill a Direct Hire Quality Engineer opening with a company in Roseville, MN. Interested candidates should have a bachelor’s degree plus 5 years of quality experience, with methodical problem-solving skills.
Quality Engineer Job Description:
- Review and approve Process Travelers, Incoming inspections, and calibration reports.
- Training QC Inspectors on incoming inspections and In-process inspections.
- Create quality standards for all in-process inspections to be used for training.
- Provide input to manufacturing documentation including inspection procedures, and manufacturing procedures, to ensure that the resulting products are consistently manufactured and tested.
- Review process improvements to ensure no new risks are introduced to the product and improvements are adequately tested and implemented to meet existing product specifications and quality standards.
- Update risk management document to reflect quality improvements with process improvements implemented.
- Conduct internal audits as assigned
- Perform review of product scrap trend charts and perform trending and/or analysis of Supplier nonconformances
- Identify opportunities for improvement utilizing Internal Auditing data and product scrap trend Analysis data
Quality Engineer Job Requirement:
- Bachelor’s Degree in Science or Engineering.
- 5+ years of experience in Quality Engineering in the medical device industry (or regulated industry).
- Experience in Manufacturing Quality is required.
- Knowledge of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables simultaneously.
- Strong mechanical aptitude and methodical problem-solving skills.
- Strong oral and technical writing skills.
- Basic statistical aptitude and experience with statistical sampling.
The starting salary for the Quality Engineer position is $60k to $70k annually DOE