QC Laboratory Supervisor

QC Laboratory Supervisor

The QC Laboratory Supervisor 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 all aspects of quality control within the organization including receiving, in-process, finished goods testing, scheduling resources, defining solutions to improve compliance, and provide key input to senior management on compliance in accordance with the requirements for ISO, FDA QSR, and STERIS policies.

Supervises laboratory activities to ensure all products are tested in accordance with company policy and Good Laboratory Practices. Supports NPD projects and completes all tasks related to the laboratory. Serves as a contact point for outside vendors, consultants and auditors. Assist with developing test methodologies and procedures. Assists / trains Lab Techs and Specialist. Works with QS on internal and external audits and audit training. Assists with developing and validating methods.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer :

Market Competitive Pay Extensive Paid Time Off and (9) added Holidays Excellent Healthcare, Dental and Vision Benefits Long / 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 continued education programs Excellent opportunities for advancement in a stable long-term career

Required :

• Bachelor degree
• Minimum eight (8) years relevant lab testing in a regulated environment (i.e. FDA / ISO 13485).
• Minimum two (2) years supervisory / leadership experience.
• Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.
• Knowledge of HPLC