Assistant Quality Manager - Audit

Job Summary

Responsible for managing the quality and compliance for supplier Quality Audit Area. Assume responsibility for a subset of individual projects that support the division, compliance, new product development per the need of the team.

Job Description

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Responsible for auditing and supporting appropriate product documentation (e.g. Device Master Records, Design Controls, Risk Management, and CE Technical Files) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to conduct audits as required.
• Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
• Manage supplier and internal audit schedule
• Identify, implement and manage the execution of continuous improvement projects.
• Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of the design, inspection, process validations, and coordinate testing to assure quality products or components.
• Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers.
• Resolve issues relating to product or production quality by interfacing with internal and external customers.
• Lead investigations of product and process non-conformances and out-of-specification results and collaborate with supplier representatives, as needed, to develop effective corrective and preventive actions (CAPA, SCAR).

Management responsibilities:

• Typically oversees teams of 2-3 employees depending on the workload and level of involvement needed with direct reports. Teams may consist of Quality Auditors
• Day-to-day operations of a group of employees;
• May have limited budgetary responsibility and usually contributes to budgetary impact;
• Interpret and execute policies for departments/projects and develops;
• Recommend and implement new policies or modifications to existing policies;
• Provide general guidelines and parameters for staff functioning;
• Key participant in hiri