Quality Technician - 2nd shift

Nextern; Osseo (MN); On-site; USD 34,000 - 51,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND生日休假

Lifetime Membership Subsidy and Well-

Life Insurance (Basic, Voluntary &

Family Leave (Maternity, Paternity)

Short-Term & Long-Term Disability

Taco Thursdays!!!

Job summary

Nextern Maple Grove is seeking a Quality Technician to ensure production and process control compliance during the development and manufacturing of medical devices. This role includes performing Device History Record reviews, supporting quality documentation, and training production staff while ensuring safe, compliant operations on 2nd shift (Mon–Thu, 3:30 PM–2:00 AM).

Ideal candidates have a HS diploma, 3+ years in quality roles, knowledge of GDP and quality testing techniques, and strong

Qualifications

• HS Diploma or GED required.
• 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 in English.
• Strong GDP experience.
• Ability to write detailed reports and other technical documents.
• Proficiency with Microsoft Office tools and basic data analysis.
• General ERP and PLM understanding.

Responsibilities

• Ensure production and process control compliance during development and manufacturing of medical devices.
• Perform comprehensive Device History Record (DHR) reviews at close of manufacturing and product release.
• Decide on handling product issues with operators and determine acceptability.
• Identify and evaluate procedures to ensure production of quality product.
• Provide technical support to the Quality group as required.
• Write technical reports and other required quality documentation.

Skills

Quality control standards

DHR review

Technical reporting

Verbal & written communication

Reading engineering drawings

GDP experience

Microsoft Office

ERP/PLM familiarity

Education

HS Diploma or GED

Tools

Microsoft Excel

Microsoft Word

Outlook

ERP

PLM systems

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.

Requirements

• 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

Benefits

• 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.