Quick overview
Job description
At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.
This position is responsible for ensuring production and process control compliance during the development and manufacturing of medical devices at the Nextern Maple Grove facility. This position may also involve quality assurance of product conformance for dimensional, electrical, and visual workmanship standards in accordance with requirements.
2nd shift - Monday through Thursday - 3:30PM to 2:00AM
RESPONSIBILITIES
- Responsible for ensuring production and process control compliance during the development and manufacturing of medical devices. Including, but not limited to, direct monitoring and correction/training of production staff.
- Perform comprehensive manufacturing Device History Record (DHR) review at close of manufacturing process and product release.
- Makes decisions on how to handle product issues with the operator accordingly and matters pertaining to whether or not product is acceptable.
- Identifies and evaluates procedures to ensure the production of quality product during manufacturing.
- Provides the Quality group with technical support as required.
- May write technical reports and other required quality documentation.
- Demonstrates safe work habits, maintains clean and safe work area.
QUALIFICATIONS
Required:
- HS Diploma or GED
- 3+ years in a quality technician or similar role
- Working knowledge of quality control standards and testing techniques.
- Excellent verbal and written communication skills.
- Ability to read, analyze, and interpret procedures and engineering drawings that are in English.
- Strong GDP experience
- Ability to write detailed reports and other technical documents.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- To perform this job successfully, an individual should have knowledge of Microsoft tools (Excel, Word, Outlook)
- General ERP and PLM understanding
Salary range: $25 to 37/hr based on skills and experience
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- Family Leave (Maternity, Paternity)
- Short-Term & Long-Term Disability
- Taco Thursdays!!!
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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