Quality Technician - 2nd Shift

Elucent Medical Inc.; Eden Prairie (MN); On-site; USD 39,000 - 44,000; Full time

Benefits offered by this job

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

Job summary

Elucent Medical is seeking a Quality Technician for 2nd shift in Eden Prairie, MN. Responsibilities include materials and product assessment testing for GMP-compliant development and manufacturing, plus in-process and final inspections and release documentation.

Supports electronic QMS and cross-functional teams to keep quality processes current. The role requires a HS diploma or 2-year degree and 2+ years in medical device quality, with strong math, computer and testing skills.

Qualifications

• HS diploma and minimum 2 years relevant medical device/ISO 13485 experience or 2 yr degree.
• Good math and technical skills.
• Excellent computer skills including MS Office.
• Knowledge of quality systems including use of electronic quality management systems software preferred.
• Knowledge of electrical and mechanical testing techniques.
• Strong organizational and time management skills.
• Excellent written and oral communication skills.

Responsibilities

• Receive and in-process inspections, material release in support of medical device manufacturing.
• Review and approve job travelers (DHRs) prior to product release.
• Support administration of quality systems within the electronic quality management system.
• Work cross functionally with process stakeholders to ensure proper documentation and timely completion.
• Develop and write quality systems procedures as requested by supervisor.
• Provide support during customer audits and Management Review preparation.
• Complete other duties as assigned by supervisor.

Skills

Math skills

Technical skills

MS Office

Quality systems knowledge

Electrical testing

Mechanical testing

Leadership

Communication

Team collaboration

Education

HS diploma or 2-yr degree

Tools

MS Office

Electronic QMS software

Job description

Job Title

Quality Technician - 2nd Shift

Schedule

Monday through Thursday

3:00pm-2:30am

Pay Range

$28.00 to $32.00

Location

On-site - Eden Prairie, MN

Reports to

Quality Engineering Manager

Education, Business Experience And Physical Requirements

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

Knowledge And Experience With Electronics Manufacturing Preferred

• Good math and technical skills
• Excellent computer skills including MS Office
• Knowledge of quality systems including use of electronic quality management systems 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.
• Demonstrate 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

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.