Sr. Quality Technician

Nextern

Maple Grove (MN)

On-site

USD 60,000 - 90,000

Full time

14 days+

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Benefits offered by this job

Health Care Plan
Retirement Plan
Paid Time Off
Birthday Holiday
Life Insurance
Family Leave
Disability - Short/Long Term
Taco Thursdays

Job summary

Nextern in Maple Grove, MN, is seeking a compliance-focused professional to ensure production and process control during development and manufacturing of medical devices. You will monitor and train staff, review DHRs, and determine product acceptability with the operator.

The role emphasizes quality documentation, procedures improvement, and collaborative support to the Quality group, with a strong commitment to safety and continuous input.

Qualifications

  • Five-year relevant experience desired.
  • Working knowledge of quality control standards and testing techniques.
  • Excellent verbal and written communication skills.

Responsibilities

  • Ensure production and process control compliance during development and manufacturing of medical devices.
  • Perform comprehensive Device History Record (DHR) review at close of manufacturing process.
  • Decide on handling product issues with operators and determine product acceptability.
  • Identify and evaluate procedures to ensure production of quality product.
  • Provide technical support to the Quality group as required.
  • May write technical reports and other required quality documentation.
  • Maintain safe work habits and a clean, safe work area.
  • Willing to give/receive constructive input and feedback.

Skills

Quality control standards
Testing techniques
Verbal and written communication
Data interpretation and reporting

Tools

Excel
Word
Outlook
ERP and PLM

Job description

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.

DUTIES AND 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.
  • Willingness to provide and receive constructive input and feedback.
  • Other duties as needed
SUPERVISORY RESPONSIBILITIES:

This job has no supervisory responsibilities.

QUALIFICATIONS:
  • Five-year relevant experience desired.
  • Working knowledge of quality control standards and testing techniques.
  • Excellent verbal and written communication skills.
LANGUAGE SKILLS:
  • Ability to read, analyze, and interpret procedures and engineering drawings that are in English. Ability to effectively present information and respond to questions from co-workers and managers.
  • Ability to write detailed reports and other technical documents.
MATHEMATICAL SKILLS:

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.

REASONING ABILITY:

Ability to define problems, collect data, establish facts, and draw valid conclusions.

COMPUTER SKILLS:

To perform this job successfully, an individual should have knowledge of: Spreadsheet Software (Excel); Word Processing Software (Word); Electronic Mail Software (Outlook).

General ERP and PLM understanding

  • 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!!!

Nexternis 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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