Quality Systems Specialist I
4 months ago
Employment Information
Quality Systems Specialist I
$500 Sign-on Bonus! Are you looking for a great work culture, good teammates, and caring leadership? Ortho Development is the place to be. We offer great benefits, working Monday through Friday. We are an exciting place to work that provides autonomy for you to excel at your tasks. Ortho Development Corporation helps people do what they love by restoring mobility. We are an orthopedic design, manufacturing and distribution company located in Draper, Utah. We offer a complete benefits package, clean work environment, and thorough training.
As a Quality Systems Specialist I, we are looking for a self-starter to work in an office environment, providing support to the Quality Systems group. This full-time onsite position is available to start immediately and is a great opportunity in the exciting medical device industry.
Schedule: Monday to Friday
Shift: Day Shift, (8:30 AM – 5:30 PM)
Your responsibilities:
- Conduct internal quality audits to verify overall compliance to ISO 13485, 21 CFR Part 820, ANVISA, MHLW and other applicable regulations.
- Conduct annual document reviews in cooperation with other departments.
- Perform effectiveness checks on completed observations.
- Assist in gathering metrics for quality systems.
- Assist in maintaining, collecting, scanning, and filing documents related to quality systems.
- Perform actions related to GUDID/UDI as needed.
- Assist in coordination of various systems or quality system functions.
- Perform other job-related duties as assigned.
Requirements:
- High School Diploma
- Experience in medical device manufacturing, or study in a science related field.
- Reading, understanding, and following quality procedures.
- General computer skills
- Working independently and staying focused on tasks
- Team player
Benefits:
We offer competitive compensation and excellent benefits including:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Retirement plan
- Tuition reimbursement
- Vision insurance
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