Senior Quality Engineer
$85,000–$85,000 year
On-siteArden Hills, Minnesota, United States
Job Summary
Develop and maintain quality engineering systems to ensure compliance with regulatory and customer requirements. Lead process validation, risk management, and continuous improvement efforts while identifying manufacturing defects and supporting corrective actions. Execute customer complaint investigations and review validation data to establish technical specifications for new products. Mentor technical team members and partner with cross-functional groups to resolve quality issues and drive operational excellence. Work onsite at the Arden Hills, Minnesota location, requiring 9 years of operations quality experience in a regulated environment.
Required Qualifications
- Bachelor's degree or higher, preferably in an engineering discipline
- Minimum of 9 years' experience in operations quality
- Strong understanding of quality operations fundamentals, regulatory requirements and quality systems
- Experience working in regulated manufacturing environments
- Experience with product risk assessment
- Experience performing root cause analysis and implementing corrective and preventive actions
- Experience with CAPA, nonconforming event and failure mode investigations
- Experience with validation engineering and process validation
- Knowledge of Quality System Regulation (QSR), ISO standards and medical device regulations
- Experience reviewing operational, test and validation data to establish technical specifications and performance standards
- Strong analytical and decision-making skills with the ability to solve complex quality issues
- Excellent communication and cross-functional collaboration skills
- Experience conducting customer complaint investigations
- Must be able to work onsite at Arden Hills, Minnesota
- Must be willing to work weekend shifts
- Must be able to lift 50 lbs
- Must be able to pass a prohibited substance test
Desired Qualifications
- Experience in the medical device industry
- Experience using data analysis to identify trends, determine root causes and implement effective solutions
- Demonstrated ability to influence stakeholders and lead quality initiatives across cross-functional teams
- Experience mentoring technical team members and providing engineering guidance
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.