Sr. Quality Technician

Nextern; Maple Grove (MN); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND

Birthday Holiday!

Lifetime Membership Subsidy and Welln…

Life Insurance (Basic, Voluntary &

Family Leave (Maternity, Paternity)

Short-Term & Long-Term Disability

Taco Thursdays!!!

Job summary

Nextern Maple Grove, MN site seeks a Quality Assurance/Manufacturing Compliance professional to ensure production and process control compliance during the development and manufacturing of medical devices. This role will involve direct monitoring and training of production staff to uphold quality standards.

You will perform Device History Record (DHR) reviews, make decisions on product acceptability with operators, and identify procedures that guarantee quality production.

Qualifications

• Five years of relevant experience preferred.
• 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; monitor and train staff.
• Perform comprehensive DHR review at close of manufacturing and product release.
• Decide on handling product issues with the operator and determine acceptability.
• Identify and evaluate procedures to ensure quality production.
• Provide technical support to the Quality group.
• Write technical reports and other required quality documentation.
• Maintain safe work area and follow safety practices.
• Willing to provide and receive constructive input and feedback.

Skills

Quality control standards

Communication skills

Tools

Excel

Word

Outlook

ERP/PLM understanding

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.