Elucent Medical Inc. · 14 hours ago
Quality Engineer II
Eden Prairie, MN
Full-time
Onsite
Mid Level
$95K/yr - $105K/yr
3+ years expElucent Medical is a medical device company focused on developing surgical navigation technologies to improve patient outcomes. The Quality Engineer II is responsible for investigating nonconformances, supporting manufacturing and development activities, and managing supplier quality to ensure high product quality and customer satisfaction.
Health CareMedicalOncology
Responsibilities
Learn how nonconformances are identified and addressed
Focus on NCMR cycle time, ensuring timely completion of actions related to nonconforming materials
Identify nonconformance trends. Develop and administer technical investigation and corrective action programs to resolve recurring quality problems
Implement standardized rework practices where appropriate to reduce potential production delays related to nonconformances identified in-process
Learn how system works and how complaint investigations are performed
Focus on complaint cycle time, ensuring timely completion of investigations
Contribute to product safety, product quality, and customer satisfaction related decisions (both data based and risk-assessment-based decisions)
Gather data related to supplier performance and work with suppliers to provide a consistently high level of quality and service
Participate in and support internal and external supplier audits and inspections
Qualification
Required
BA/BS degree in science, engineering or technical field or equivalent experience
Demonstrated skills in statistical analysis
Strong computer skills
Individual must have a hands-on approach
Strong organizational and time management skills
Maintains positive attitude when working with peers, customers or suppliers
Capable of leading a product investigation team and/or working with internal and external customers to resolve product quality issues
Works effectively on cross functional teams to establish appropriate processes pertaining to quality
Excellent written and oral communication skills
Ability to formulate responses to common inquiries or complaints from customers and regulatory agencies
Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations
Preferred
3 years' experience as a Quality Engineer in the medical device industry
Medical device quality management systems including 21 CFR Part 820 (QSR) and ISO 13485 (or aerospace AS9100)
Electromechanical device/system experience
Experience with nonconforming material investigations, manufacturing quality support, and risk management
Benefits
401(k)
401(k) matching (4%)
Dental insurance
Health insurance
Vision insurance
Paid Holidays
Paid Vacation Days
Paid Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Pet Insurance
Employee Assistance Programs
Company
Elucent Medical Inc.
At Elucent Medical, we’re pioneers in the realm of healthcare innovation, driven by a commitment to revolutionize patient care.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$92.1MKey Investors
Trinity Capital
2025-01-27Series Unknown· $30M
2024-04-10Series C· $42.5M
2019-07-01Series Unknown· $12M
Leadership Team
Jason Pesterfield
President, CEO & Director
Recent News
2025-02-07
Company data provided by crunchbase