Sr Quality Control Technician, IQC

About the role

Prepare inspection plans and coordinate with Manufacturing Inspectors the completion of product inspections to meet production demand. Conduct inspection and testing following controlled procedures and test methodology, performing final product acceptance testing. Record and analyze inspection and testing data to determine if acceptance criteria has been met. Review completed production lot history records to ensure completeness and good documentation requirement have been met. Perform production line audits to ensure process steps are being followed by the production staff. Initiate nonconformance process when inspection criteria failed to meet specifications, describing in detail observed defects. Assist in the disposition activities for nonconforming material. Participate in investigations and root cause analyses for identified issues and recommend improvements. Coordinate calibration and preventative maintenance for equipment in quality control laboratory. Assist in the qualification and installation of inspection/testing equipment. Proactively support continuous improvement and lean manufacturing processes. Make and implement recommendations for quality system improvements.

Responsibilities

• Prepare inspection plans and coordinate with Manufacturing Inspectors the completion of product inspections to meet production demand.
• Cover inspection and testing following controlled procedures and test methodology, performing final product acceptance testing.
• Record and analyze inspection and testing data to determine if acceptance criteria has been met.
• Review completed production lot history records to ensure completeness and good documentation requirement have been met.
• Perform production line audits to ensure process steps are being followed by the production staff.
• Initiate nonconformance process when inspection criteria failed to meet specifications, describing in detail observed defects.
• Absorb assistance in the disposition activities for nonconforming material.
• Participate in investigations and root cause analyses for identified issues and recommend improvements.
• Cover calibration and preventative maintenance for equipment in quality control laboratory.
• Absorb assistance in the qualification and installation of inspection/testing equipment.
• Proactively support continuous improvement and lean manufacturing processes.
• Make and implement recommendations for quality system improvements.

Requirements

A minimum of 4 years of quality control experience in the medical device industry; or equivalent combination of education/training and work experience. Experience working with catheters, endovascular or neurological devices. Working knowledge about quality system requirements (FDA 21 CFR Part 820 and/or ISO 13485), as they relate to quality control processes and good manufacturing practices. Strong communications skills (written and verbal). Strong ability to perform multiple tasks concurrently with high level of accuracy.

Qualifications

None specified.

Skills

Strong communications skills (written and verbal). Strong ability to perform multiple tasks concurrently with high level of accuracy.

Benefits

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Pay

Salary Range: $79,000 – 86,000/annually

Schedule

This position is on site and full time.