Quality Technician

Elucent Medical Inc.; Eden Prairie (MN); On-site; USD 37,195 - 39,950; Full time

Benefits offered by this job

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

Job summary

Elucent Medical Inc. is seeking a Quality Technician in Eden Prairie, MN to ensure product quality for medical devices. The technician will conduct inspection and testing, and support quality systems in compliance with GMP standards.

The role requires a HS diploma and a minimum of 2 years relevant experience. Responsibilities include performing inspections and documentation while working closely with cross-functional teams to uphold quality.

Comprehensive benefits including health insurance and a retirement savings plan are provided.

Qualifications

• Minimum 2 years of relevant medical device/ISO 13485 experience.
• Strong organizational and time-management skills.
• Excellent written and oral communication skills.

Responsibilities

• Perform materials and product assessment testing in compliance with GMP.
• Conduct functional testing and inspections of components.
• Develop and write quality systems procedures.

Skills

Good math and technical skills

Excellent computer skills including MS Office

Knowledge of quality systems and electronic quality management system software

Knowledge of electrical and mechanical testing techniques

Education

HS diploma or 2-year degree

Job description

Job Title

Quality Technician

Reports To

Quality Engineering Manager

Pay Range

$27.00 to $29.00

Location

On-site - Eden Prairie, MN

Education, Business Experience and Physical Requirements

HS diploma and minimum 2 years relevant medical device/ISO 13485 experience or 2‑year degree.

Knowledge and Experience With Electronics Manufacturing Preferred

• Good math and technical skills
• Excellent computer skills including MS Office
• Knowledge of quality systems and electronic quality management system software preferred
• Knowledge of electrical and mechanical testing techniques

Required Competencies

Leadership / Personal Conduct

• Maintains positive attitude when working with peers, customers or suppliers.
• Comfortable working in a self‑directed team environment and giving or asking for instructions.
• Demonstrates an understanding of the medical industry.
• Works effectively on cross‑functional teams to establish appropriate processes pertaining to quality.
• Individual must have a hands‑on approach.
• Strong organizational and time‑management skills.

Communication

• Excellent written and oral communication skills.
• Positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
• Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions.

Description of Responsibilities

The Quality Technician performs materials and product assessment testing in support of medical device development and manufacturing in compliance with GMP. The individual is responsible for receiving and in‑process inspections, material release in support of medical device manufacturing. The Quality Technician may be called upon for reviewing and approving job travelers (DHRs) prior to product release.

In addition, the Quality Technician will support administration of quality systems within the electronic quality management system, as assigned. In this role, the position works cross‑functionally with process stakeholders to ensure quality system processes are documented appropriately and are completed within the expected timeframes.

Other duties may be assigned.

Key Result Areas

Development / Manufacturing Support

• Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions.
• Responsible for receiving inspection activities including, but not limited to inspection and gathering all defined requirements and documentation to release parts/components.
• Responsible for performing in‑process and final component, sub‑assembly and product inspection.
• Document non‑conformance reports once parts fail specification or requirements.
• Performs and/or supports troubleshooting, investigations and problem solving of issues and non‑conformances.
• Assures quality systems documentation and record‑keeping activities are carried out and completed in compliance with established procedures and work instructions.
• Demonstrates safe work habits; maintains clean and safe work area.
• Completes all other duties as assigned by supervisor.

Quality Systems

• Develop and write quality systems procedures as requested by supervisor.
• Provides support during customer audits.
• Supports supervisor in preparation of Management Review.

Company Benefits

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.

• 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