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.

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 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.

Qualifications

* 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.