Supervisor, Quality Control
Fort Lauderdale, FL Posted: 5/7/2021
Role: Supervisor, Quality Control
Location: Fort. Lauderdale, Florida
We are looking to hire Quality Control Supervisor to support our client"s (Medical Device Organization) need for logistical, clerical and technical support to the Clean Room programs. In this role you would supervisor a team of inspectors and ensure workflow and appropriate use of sampling plans/tools.
Duties & Responsibilities:
- Supervises a team of several inspectors in the Bolton Clean Room.
- Must be able to analyze trends and recommend appropriate changes to sampling plans, procedures, inspections methods, or tooling.
- Recommends modifications / improvement where advisable to minimize cost and labor.
- Coordinates and participates in audits whether that be internal or external to ensure quality compliance.
- Must be able to evaluate and implement changes for efficiency and effectiveness of inspections.
- Analyzes and investigates both in‑house and field data, reports quality problems, recommends corrective action, and follows‑up on the implementation and effectiveness of solutions.
- Assure Clean Room responsibilities are carried out in compliance with applicable quality systems (i.e.ISO13485, 21CFR820).
- Interface with Research and Development and other engineering departments to determine if process or product changes are needed based on NCR investigations.
- Requests and confirms corrections, corrective actions, and/or preventive actions from suppliers, engineers (as needed) to ensure that non-conformances are properly corrected and recurrence is prevented.
- Updates Clean Room Quality procedures/documents as needed to ensure efficient workflow and appropriate use of equipment/tools, and sampling plans.
- Facilitates Clean Room inspector training and ensures relevant training requirements are up to date.
- Manages Clean Room non-conformance report generation, tracking and closure.
- BS in Engineering or more than 5 years in the Medical Device industry with more than 5 years of experience in the quality field.
- Familiarity with management of non-conforming product.
- Familiarity with sampling plans, and failure analysis investigations.
- Excellent Written and Verbal Communication
- Understanding of quality system regulations (ISO13485, 21CFR820)
- Ability to interact with all levels within organization
- Analytical skills for compiling and analyzing data.
- Knowledge of sampling plans.
- Computer and software skills
- Ability to motivate others and improve efficiency
Established in 1995, PTS Advance provides people and tools to companies that want to do more than just "fill a position". Our expertise includes attracted and retaining key talent, while managing assignments in a safe, compliant, and transparent manner. We are honest and transparent in the process because we put you first.
Interested? Contact Allison Sudman at 949-268-4081 or via email at Allison.Sudman@PTSadvance.com for a confidential discussion!
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