Manager, Quality Engineering

Overview

The Quality Engineering Manager serves on a cross functional team, ensuring the adequacy, suitability and compliance of specified Quality Management System processes. Manages day-to-day quality operations and provides leadership and direction to the functional team.

• Approve quality documents, analyze improvement of the QMS and other department processes, including reviewing, updating, creating, and implementing SOP’s to support improved processes and compliance.
• Provide quality expertise and leadership to management and operational personnel.
• Responsible and authority for ensuring that processes needed for the quality management system are documented; reporting to top management on the effectiveness of the process(es) and the need for improvement; promoting the awareness of applicable regulatory and quality management system requirements throughout the organization.
• Prepare, communicate and monitor quality plans and metrics to support operations.
• Maintain the process in the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Attend, present and provide data for meetings to include project updates and reviews.
• Participate in hiring, interviewing and on boarding process of new hires.
• Responsible for performance management and annual reviews of direct reports.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

• Bachelor's degree in Engineering or Life Science or experience of such kind and amount as to provide a comparable background.
• Minimum of 5 years experience in a regulated industry, preferably in a medical manufacturing environment.
• Minimum 3 years experience working with quality management system.
• Previous leadership experience, 5 years preferred.
• Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects.
• Works under general office environment conditions.
• Utilizes close visual acuity for working with computers and equipment.
• Frequently required to stand, walk, and communicate.
• Occasionally lifting with minimal exertion during shift.