Manager, Quality Engineering
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
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 SOPs 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
- Bachelors 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.
Required Experience:
Manager
Key Skills
- Hospitality Experience
- Go
- Management Experience
- React
- Redux
- Node.js
- AWS
- Mechanical Engineering
- Team Management
- Leadership Experience
- Mentoring
- Distributed Systems
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
