Quality Manager - NAMIC

Job Summary

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (e.g. QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Act as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during the investigation process.
• Identify and manage the execution of continuous improvement projects.
• Afford the division in product evaluation from a quality assurance and regulatory compliance standpoint.
• Afford the planning of the design, testing, inspection, and process validations to assure quality products or components.
• Ensure all quality issues are resolved to customer satisfaction, in a timely manner.
• Resolve issues relating to product or production quality by interfacing with internal and external customers.

Requirements

• Educational Background: Bachelor’s degree in Engineering, Science, or Technical Field, or relevant experience.
• Work Experience: At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
• Knowledge/Skills/Abilities: Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.), proficiency in analyzing and reporting data, demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines, advanced level skill in Microsoft Excel (e.g. using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).

Preferred Requirements

• Work Experience: At least 2 years of supervisory/managerial experience.
• Experience: In Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.