Head of Quality Assurance and Quality Control

Description

Corporate Statement

Nephron Nitrile is a new privately-owned Nitrile Glove manufacturer. Nephron Nitrile products are proudly made in the USA! We are headquartered in West Columbia, South Carolina. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability.

Position Summary:

Provide leadership and direction in the implementation of end-to-end prevention-based quality systems to ensure the development, manufacture, and distribution of products are safe, effective and meet regulatory requirements.

Responsible for the management of Quality Assurance and Quality Control (QA & QC) staff supporting the manufacturing plant. Drive compliance to internal and external regulatory requirements. Facilitates the closure of significant quality and product issues. Works closely with Manufacturing and R&D to support business objectives.

The Head of Quality Assurance and Quality Control reports to the Vice President of Quality Operations. This position has the following key accountabilities:

• Executing and implementing enhancements to existing QA & QC functional systems in a manner that effectively supports the growth of the business. To that end, a key responsibility of this position is to have an understanding business needs and strategic plans.
• The development and implementation of evaluation methods to ensure product quality meets regulatory and customer expectations.
• Managing the deployment and execution of root cause analysis tools to support nonconformance, complaint and CAPA investigations.

Primary Responsibilities: 

• Leadership to site’s Quality Assurance and Quality Control teams.
• Ensures the organization attracts, develops and retains the best talent for QA/QC teams.
• Provide coaching, mentorship and training in technical, managerial, and administrative skills in order to meet the development needs of team members.
• Ensures that manufacturing activities adheres to NNL’s QMS requirements
• Develops strategies to improve compliance and efficiency of applicable QMS procedures
• Identify, address and elevate as appropriate QA/QC teammates concerns
• Escalates to internal business partners those relevant incidents related to site’s operations
• Manage all aspects of plant-based quality including cost reduction, process reliability, problem resolution, complaint investigation, document control, and CAPA.
• Provide Quality functional leadership and expertise to the organization such that it contributes to the development, manufacture, and distribution of safe and effective products.
• Provides QAQC direction on projects impacting products, processes, or material changes related to commercially marketed product, including product improvements and line extensions.
• Establish and maintain a strong failure investigation resolution system for all internal and external quality issues. Interact directly with production, marketing, R&E, and other departments, as required with respect to product failure reporting, investigation and resolution.
• Provide functional direction to the Quality teams by implementing and maintaining quality policies, instructions, and control procedures.
• Monitors manufacturing processes quality performance and implement the necessary strategies to ensure products quality in daily operations.

Requirements

Knowledge, Skills & Abilities:

NOTE: The primary accountabilities and knowledge, skills and abilities listed below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• Bachelor's degree in the physical sciences or engineering
• 5 years Quality Assurance or Quality Control background 
• Strong experience in a manufacturing environment
• Experience should include in-depth knowledge of domestic (FDA) and International regulatory requirements for the medical device industry
• Lean-Six Sigma trained is strongly preferred
• Proficient in MS Word, Excel, PowerPoint
• Ability to effectively communicate verbally and in written through the command chain
• Strong attention to detail
• Team Player, must be able to interact within the company with all departments
• Strong analytical/problem-solving skills with demonstrated ability to collect, summarize and report technical information.
• Experience in Root Cause Analysis and technical writing skills
• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
• The ability to effectively manage oneself, multi-task, demonstrates integrity, & be productive under pressure and achieve development goals
• The ability to take strategic objectives and manage oneself, accept accountability to drive results through effective actions and prioritization.