Overview

The Senior Manager, Quality Assurance serves on a cross functional team ensuring the adequacy, suitability and compliance of processes governing product realization. Provides senior leadership and direction to quality engineering teams.

Responsibilities

- Oversight and review of product life cycle activities from a quality engineering perspective, including premarket/ product development, supplier management, manufacturing, sterilization, and post-market.- Working with subject matter experts, process owners, subsystem leaders, executive management and IT in helping to assess and report applicable quality system data, triggering action where necessary.- Helping to ensure that issues requiring improvement are identified and escalated appropriately.

- Working and interacting effectively and professionally with and for others throughout various levels of the global organization.

- Manage internal and external Audit programs, NC/CAPA processes, Document Management, Management Review, Post Market Surveillance, and Quality Systems Projects.

- Moniter, report, and drive Quality Metrics across the business.

- Identify and implement Continuous Improvement activities within Quality Systems

- Work across other Cook Medical entities and corporate to drive alignment and efficiencies

- Excellent organizational skills.- Must be detail oriented.- Maintain accurate and timely reports and records.

- 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

- Bachelors degree in a technical discipline; Master's degree preferred- 10 years experience in quality systems- 5 years experience in FDA-regulated industry, medical device experience preferred- 3 years management experience- Knowledge of medical device regulations, pertinent standards and guidances- Knowledge of quality tools & principles- Proven written and verbal communication skills- Basic knowledge of statistics- Proven problem solving skills

Physical Requirements:

- Full time on-site position

- Works under general office environmental conditions- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.- Some travel involved- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

Requisition ID2024-14393

Posting Date1 day ago(4/26/2024 10:45 AM)

Job Location(s) Bloomington IN United States

Travel Less than 10%

Position Type Full Time

Company Cook Inc - Bloomington

Category Quality