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.

Responsibilities

- 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 minimalsupervision.

- 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 withminimal supervision.- Ability to remain calm and receptive in fast paced situations.

Qualifications

• Bachelor's degree in Engineering

• Minimum 3 years experience in a regulated industry, preferably in a medical manufacturing environment

• Minimum 3 years experience working with quality management system

• Previous leadership experience

• Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects

 

Physical Requirements:

• Works under general office environment conditions

• Utilizes close visual acuity for working with computers and equipment

• Frequently required to stand, walk, and hear

• Occasionally required to lift up to 20 pounds

 

 

 

 

 

 

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