Manager, Quality Engineering

Overview

Job Summary

Autoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements, as well as all company policies. Responsible for ensuring department goals are met and budgets are managed. Responsible for implementing and improving processes, procedures and policies that enable and encourage optimum performance of the people and resources within assigned area.Responsible for managing and leading the work of direct and indirect reports, both individual contributors and people managers. Activities are performed in accordance with standard operating procedures (SOPs), Quality Systems Regulations (QSRs), Human Resources, EHS and other company policies. As a member of the Werfen management team is responsible for role modeling Werfen Values and Role of the Manager competencies and expectations.

Within Quality Engineering, the Manager position is responsible for the following, under the direction of Department Leadership. Responsible for leading a team of technical staff to advise and assist in developing, applying, and implementing methods, tools, and practices to achieve product quality goals and requirements in the areas of new product development, as well as production, testing, distribution, maintenance, and support of on-market products. Provides leadership, support, and input to the organization related to design assurance, risk management, design changes, component and process quality, problem solving, statistical techniques, test method development, non-conforming product investigations, corrective and preventive actions, and continuous improvement.

Responsibilities

Key Accountabilities

• Teamwork: Coordinate with Department Leadership and other cross-functional areas including R&D, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects, risk management, failure analysis, process validation, product capability, trend analysis, and statistical process controls. Model effective team collaboration behavior.
• Product and Process Life Cycle: Assist Department Leadership in developing, improving, implementing, and maintaining Quality Management procedures that ensure design and development, production, and post-production (post-market) activities that efficiently define, meet, and maintain customer, technical requirements, and regulatory requirements with objective evidence in accordance with applicable regulations and standards, per company goals. Assist Leadership in defining and driving improvement projects and initiatives that reduce systemic manufacturing defects.
• Risk Management: Maintain current knowledge of applicable requirements for risk management activities and produce audit ready risk file documents in compliance with the requirements of current international risk management standards and regulations. Coordinate evaluation of new and emerging risk standards. Assist in the development of plans for meeting and complying with new risk regulations, guidance, and standards.
• Quality Science and Engineering: Perform independent quality review and evaluation of change orders including related data for scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance to applicable regulations and standards. Provide direction from a quality perspective for cross-functional interactions regarding process and product compliance/quality optimization. Provide input to product requirements, acceptance criteria, process monitoring, product evaluation, failure investigation, and complaint analysis. Ensure appropriate statistical tools and techniques are followed. Collect and analyze defined quality metrics and quality-related data to identify issues or trends.
• Quality Management Systems: Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Aid in designing and documenting new and revised quality systems for product realization compliance with applicable regulations and standards. Escalate events that may contribute negatively to medical device safety or efficacy. Address and remediate events that may contribute negatively to QMS processes or effectiveness.
• Audit: Support internal, and third-party audits, regulatory inspection preparation and execution. Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
• Department Planning: Establish and monitor strategies, priorities and goals for risk management, process validation, process relia