Sr Quality Control Technician

Imperative Care; Campbell (CA); On-site; USD 79,000 - 86,000; Full time

Benefits offered by this job

Stock options

401k plan

Health benefits

Generous PTO

Parental leave

Job summary

Imperative Care in Campbell, CA is seeking a Sr Quality Control Technician to join our on-site, full-time manufacturing and quality team. You will lead inspection planning, perform testing, and ensure product conformance against strict quality standards.

The role requires 4+ years in medical device QC, experience with catheters or neuro devices, and solid knowledge of FDA 21 CFR Part 820 and ISO 13485. Strong communication and multitasking abilities are essential.

Qualifications

• 4+ years of quality control experience in the medical device industry.
• Experience with catheters, endovascular or neurological devices.
• Knowledge of quality system requirements (FDA 21 CFR Part 820 and ISO 13485).
• Strong written and verbal communication skills.
• Ability to multitask with high accuracy.

Responsibilities

• 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.

Skills

Quality control

Medical devices

Regulatory knowledge

Communication skills

Multitasking

Tools

FDA 21 CFR Part 820 knowledge

ISO 13485 knowledge

Job description

Job Title: Sr Quality Control Technician

Location: This position is based in our Campbell, California offices. This position is on site andfull time.

Why Imperative Care?

Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated.As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.

What You’ll Do

• 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.

What You’ll Bring

• 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.

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.

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

Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.

The posted salary range reflects compensation for employees based in the local Bay Area market. For candidates hired outside of this geographic area, compensation may vary and be adjusted based on location, local market conditions, and other factors