QC Scientist

The QC Scientist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards.

This position is responsible for generating quality control initiatives with minimal supervision including developing test methods and troubleshooting lab and product issues in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to developing test methodologies and validation methods, and audits. The QC Scientist leads non conformances, complaint and CAPA investigations, supplier quality improvement efforts, manufacturing and process control improvements, and product and service quality enhancements through the application of statistical methods and established quality principles.

This position requires working onsite in our St. Louis, Missouri manufacturing facility during core business hours.

• Lead projects focused on chemical raw material and product quality.
• Assist with developing test methodologies and procedures.
• Works with Quality System on internal and external audits.
• Assists with developing and validating methods.
• Support and / or develop chemical testing procedures.
• Coordinate Failure Investigations by designing and performing lab scale simulation of products made in the plant.
• Troubleshoots & calibrates Lab equipment.
• Assists with directing work of lab employees.

Required:

• Bachelor's degree in Science or related technical field with hands on Chemistry experience.
• Minimum 6 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required.
• Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.

Preferred:

• Bachelor of Science degree in Chemistry, Biology, Chemical Engineering or Physics.
• Ability to lead cross functional team meetings sometimes involving Directors and above.
• Ability to manage multiple priorities in a fast-paced production environment.
• Ability to pivot and reprioritize quickly to meet Customer Needs.

Other:

• Ability to work in a fast-paced environment with strict deadlines.
• Empowerment: Make recommendations on improvements to test methods and procedures.
• Decision Making: Make decisions on experimental steps and data analysis within defined parameters and guidelines.
• Problem Solving Authority: Recognize and communicates unexpected experimental results, interpret data with minimal direction, participate in defining next steps, and perform research, needed.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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