Medical Device Quality Technician - ISO 13485 Focus

Lesjöfors; Pittston (Luzerne County); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

PTO up to 5 weeks annually

401k plan with enhanced employer-conb

Short-Term and Long-Term Disability

Eleven paid holidays per year

Annual bonus opportunity

Job summary

Lesjöfors Springs America is seeking a hands-on Manufacturing Quality Technician to support its growing medical segment at the Pittston, PA location. You will inspect materials, record QC data, and work with the production team to prevent scrap while ensuring 100% quality for customers.

The role requires ISO 9001 knowledge with ISO 13485 preferred. Ability to read/write simple instructions and travel up to 5% for training or audits is expected.

Qualifications

• Bachelor’s degree in quality/manufacturing or equivalent and manufacturing quality experience.
• High school diploma with 5+ years in quality department in manufacturing accepted.

Responsibilities

• Inspect/test materials, products, and equipment to meet medical device quality standards.
• Record data from QC tests and prepare reports.
• Collaborate with production to identify and correct quality issues and reduce scrap.
• Develop and implement QC procedures, including checklists and testing protocols.
• Perform routine audits of processes to identify quality improvements.
• Provide training and support to production personnel on QC processes.
• Coordinate with engineering and supply chain to ensure quality throughout production.
• Program and operate measurement equipment to assess dimensions and tolerances.
• Maintain a safe, clean work environment and follow company policies.
• Pursue ongoing training to stay updated on industry trends.

Skills

Quality control

SPC analysis

Data interpretation

Communication

Team player

Self-starter

Travel flexibility

Education

Bachelor’s degree in quality/manufacturing

High school diploma with 5+ years experience

Tools

ISO 9001 knowledge

ISO 13485 knowledge

Job description

Lesjöfors Springs America is seeking a hands-on Manufacturing Quality Technician to support its growing medical segment at the Pittston, PA location. You will inspect materials, record QC data, and work with the production team to prevent scrap while ensuring 100% quality for customers.

The role requires ISO 9001 knowledge with ISO 13485 preferred. Ability to read/write simple instructions and travel up to 5% for training or audits is expected.