Senior QC Technician

Description

The Company
The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics, a bioMerieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner than existing methods, saving patients suffering from drug-resistant

The Job

1. Ensure that all materials received from suppliers meet specifications
2. Ensure that finished device(s) assembled in the production area meet all required Quality Control requirements as stipulated in the either the assembly work instructions or final inspection procedures
3. After approving the production processes by confirming specifications and conducting visual and measurement tests, monitor the operations to ensure they meet the approved systems, communicating any required changes to the production supervisor
4. Maintain detailed records of the testing that’s been carried out
5. Monitor quality control metrics such as the percent defects detected, inspection volume and turnaround time
6. From the data collected from inspections, create reports to highlight issues, detail the number of defective products being produced, and explain where improvements can be made
7. Inspect, test, or measure materials using gauges, calipers, and micrometers, as well as operating electronic inspection equipment
8. Monitor production areas, ensuring they meet health and safety compliance, and check that all manufactured products or parts meet the necessary production standards
9. Verify documentation accuracy and compliance to established procedures.
10. Trains new employees.
11. Assists in the review and approval of documentation.
12. Maintains accurate filing systems.
13. Supports audit activities related to documentation practices and assists in implementing corrective and preventive actions.
14. Performs all work in compliance with company policy and within the guidelines of the Quality Management System

1. Technical degree and 5 years experience in a quality control setting (8 years without a degree)
2. Knowledge of quality principles applicable to medical device products, including FDA QSR and ISO 13485.
3. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
4. Strong written communication skills and attention to detail are required.
5. Expert ability to use precision mechanical measuring instruments, and other various electrical test equipment.
6. Ability to read and interpret complex blueprints.  Knowledge of geometric dimensioning and tolerancing (GD&T) a plus
   

The estimated salary range for this role based in California is between $65,000 and $79,000 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. 

In addition, bioMérieux offers a competitive Total Rewards package that may include:

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves