Quality Engineer II

Elucent Medical•Eden Prairie, MN

8h•$95,000 - $105,000•Onsite

About The Position

Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes. The Quality Engineer II is responsible for investigating and processing nonconformances, investigating complaints, supporting manufacturing and development activities, performing incoming and final inspections, implementing corrective and preventive actions, and managing supplier quality. This individual may perform other functions as required.

Requirements

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.

Nice To Haves

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.

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.