Quality Inspector II – Onsite Medical Device QC

abbott; Minnetonka (MN); On-site; USD 29,000 - 58,000; Full time

Benefits offered by this job

Health coverage in HIP PPO plan

Excellent retirement savings with high

Tuition reimbursement

FreeU education benefit

Career development in an international

Recognition as a great place to work

Diversity and inclusion programs

Job summary

Abbott in Minnetonka, MN is seeking a Quality Inspector II to support quality engineering in new product development, manufacturing and services. This onsite role includes performing inspections, documenting nonconformances, and helping maintain calibration and test equipment.

You will work with engineers and quality teams to ensure compliance with FDA regulations and ISO 13485, applying blueprints, sampling techniques and Gage R&R methodologies.

Qualifications

• Associates degree or completion of a 2-year technical program or equivalent experience.
• 2-4 years' experience in quality or related field.
• Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
• Experience with optical measurement equipment, hand tools, gauges and fixture design.
• Training in blueprint reading and sampling techniques.

Responsibilities

• Perform first article incoming inspection of purchased components and inspection of production operations with documentation.
• Document nonconformances as appropriate.
• Monitor and calibrate/test equipment and fixtures.
• Initiate related documentation changes.
• Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
• Collect data, summarize, and document test results.
• Assist with Gage R&R studies.
• Assist with selecting, installing and programming precision measuring equipment.
• Create and maintain control plans for products and processes.
• Support QMS/EMS and regulatory compliance programs.

Skills

Quality systems

FDA regulations

ISO 13485

Optical measurement equipment

Blueprint reading

Data analysis

Documentation/Reporting

Team collaboration

Education

Associates degree or 2-year technical program

Tools

Gage R&R

Calibration

Test methods

Job description

Abbott in Minnetonka, MN is seeking a Quality Inspector II to support quality engineering in new product development, manufacturing and services. This onsite role includes performing inspections, documenting nonconformances, and helping maintain calibration and test equipment.

You will work with engineers and quality teams to ensure compliance with FDA regulations and ISO 13485, applying blueprints, sampling techniques and Gage R&R methodologies.