Quality Engineer II

Job Title:

Quality Engineer II

Department:

Quality and Regulatory

Reports to:

Quality Engineering Manager

Work Location:

In-Person

Pay Range:

Based on Experience - $95,000.00 to $105,000.00

Position Type and Expected Hours of Work:

Full-Time, Monday-Friday, 40 hours/week

About Elucent Medical:

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.

Job Summary:

The Quality Engineer II is responsible for investigating and processing nonconformances, investigating and closing 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.

Supervisory Responsibilities:

None.

Job Responsibilities:

Nonconforming Materials

• Process nonconformances, identify root causes, and act accordingly.
• Focus on NCMR cycle time, ensuring timely completion of actions related to

nonconforming materials.

• Identify nonconformance trends. Develop and administer technical investigations 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.

• Prepare and present weekly metrics regarding nonconformances to ensure tasks are being

completed appropriately.

Complaints

• Manage complaint investigations as assigned.
• Identify root cause using technical knowledge of hardware and software-related issues.
• Focus on complaint cycle time, ensuring timely completion of investigations.
• Identify complaint trends. Develop and administer technical investigations and corrective action programs to resolve recurring issues as needed.

Internal and External Quality Performance

• Contribute to compliance regarding product safety, product quality, and customer satisfaction-related decisions (both data-based and risk-assessment-based decisions).
• Perform investigations related to supplier performance and work with suppliers to provide

a consistently high level of quality and service.

• Work directly to assign and review SCAR (Supplier Corrective Action Request) investigations to ensure the supplied product meets specifications.
• Assist with internal and external supplier audits and inspections.
• Act as a SME (Subject Matter Expert) during QMS (Quality Management Systems) audits.
• Perform audit support activities as directed

Qualifications

Education and Experience:

• BA/BS degree in science, engineering or technical field or equivalent experience.
• Preferred: 3 years’ experience as a Quality Engineer in the medical device industry.
• Preferred: Medical device quality management systems including 21 CFR Part 820 (QSR) and ISO 13485 (or aerospace AS9100).
• Preferred: Electromechanical device/system experience
• Preferred: Experience with nonconforming material investigations, manufacturing quality support, and risk management.

Required Skills/Abilities:

• 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.

Physical Requirements / Work Conditions:

• Percentage of travel 10%
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Office, Manufacturing floor

Elucent Medical Benefits, Culture And Work Environment

At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits, including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.

Full-time employees are provided:

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

Affirmative Action / EEO Statement

Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.