POSTED 06/05/2025
Senior Quality Engineer
Location: Roseville, MN
Senior Quality Engineer
Roseville, MN
Currently looking for a skilled individual to fill a Direct Hire Senior Quality Engineer opening with a company located in Roseville, MN. Interested candidates should have a bachelor’s degree in a related field, experience working in a regulated manufacturing industry, and knowledge of FDA, GMP, GDP, and ISO 13485 compliance requirements.
Senior Quality Engineer Job Description:
Roseville, MN
Currently looking for a skilled individual to fill a Direct Hire Senior Quality Engineer opening with a company located in Roseville, MN. Interested candidates should have a bachelor’s degree in a related field, experience working in a regulated manufacturing industry, and knowledge of FDA, GMP, GDP, and ISO 13485 compliance requirements.
Senior Quality Engineer Job Description:
- Follow established procedures, GDP (Good Documentation Practices), and GMP (Good Manufacturing Practices).
- Assist with administration of document control system including establishment and updates of product documentation such as Design History Files (DHR), Devie Master Records (DMR), and manufacturing process packages.
- Provide a leadership role for ongoing quality improvement projects (i.e. tooling and equipment records management, production documents improvement plan, gold standards management).
- Support and facilitate ongoing quality events (e.g. management reviews, staff training, audits, webinars).
- Assist with administration of product sterilization processing and testing (i.e. sterility, bioburden, pyrogen).
- Monitor and trend quality data (e.g. bioburden and pyrogen test results, manufacturing scrap).
- Assist with non-conformance documentation creation, administration, and trending (i.e. NCR’s, deviations, SCAR’s).
- Provide timely quality review of manufacturing documentation (e.g. process packages and travelers, NCR’s, tooling records).
Senior Quality Engineer Job Requirement:
- Bachelor’s degree in science, Engineering, or a related field, or a combination of education and work experience totaling at least 4 years.
- 1-year minimum experience in manufacturing, specifically in a regulated industry, medical device or pharmaceutical industry preferred.
- Ability to understand specifications, tolerances, and units, and use of standard measurement equipment.
- Familiar with QC sampling plans.
- Knowledge of FDA, GMP, GDP, and ISO 13485 compliance requirements.
- Proficient in computer software use (e.g., Work, Excel, and spreadsheets).
- Beneficial to have work experience utilizing an electronic Quality Management System (eQMS).
- Strong command of the English language, with the ability to read, write, and communicate fluently.
- Legible handwriting for documentation and record keeping purposes.
- High attention to detail.
- Ability to work in a team environment.
- Proficient quality systems knowledge and aptitude.
- Accountable, self-starter and ability to work with minimal supervision.
- Ability to multitask, meet deadlines, and navigate effectively in a fast-paced environment.
- Good interpersonal and verbal/written communication skills.
Compensation for Senior Quality Engineer:
The starting salary for the Senior Quality Engineer position is $75,000 to $80,000 annually. Plus, benefits (health insurance, dental insurance, paid time off, 401(k), HAS, and profit-sharing opportunities (depending on company/employee performance))
The starting salary for the Senior Quality Engineer position is $75,000 to $80,000 annually. Plus, benefits (health insurance, dental insurance, paid time off, 401(k), HAS, and profit-sharing opportunities (depending on company/employee performance))