Quality Assurance Manager

Quality Assurance Manager - $100k - $120kRichboro, PAUS Citizens or GC holders onlyNo C2CCould you be my clients next Quality Assurance Manager? Leading their manufacturing quality team and ensure that all parts of the manufacturing process meet strict specifications. In this leadership role, you will be responsible for developing, managing, implementing, and continuously improving Quality Management Systems and processes. Your contribution will play a crucial role in advancing the company's position within the industry.Key Responsibilities:Oversee the daily operations of the Quality Department to meet set goals and objectives.Serve as the primary quality representative for existing and new products, leading and developing all aspects of Quality Assurance within manufacturing processes.Review and approve quality documentation, including validation reports, product test protocols, change management, CAPA, customer complaints, and audits.Develop and manage policies, procedures, and work instructions to ensure organizational compliance.Identify and mitigate risks, applying a risk-based approach to decision-making and issue resolution.Collaborate across departments (e.g., Engineering, Manufacturing, Supply Chain) to ensure compliance with corporate eQMS.Lead continuous improvement initiatives and monitor key performance indicators.Manage internal and external audits, and support supplier and customer Quality Agreements.Drive performance improvement through regular team meetings to enhance customer satisfaction and reduce non-conformances.Build strong, trusted relationships with all departments and contribute to broader organizational goals.Education, Skills, and Experience Requirements:Bachelor's degree in Engineering or a related field.5-7+ years of experience in a Quality Assurance leadership role (life sciences or medical device experience is strongly preferred).Working knowledge of ISO 9001; familiarity with ISO 14001, 45001, 13485, and other relevant standards is highly desirable.Proficiency in traditional and modern quality management tools and practices.Experience with Six Sigma andor Lean Manufacturing methodologies is a plus.Strong computer skills and proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).Excellent organizational skills and the ability to manage multiple priorities in a fast-paced environment.Exceptional communication skills, able to interact with all levels of the organization and external customers.Ability to manage stress and deadlines effectively.

Created: 2025-02-14