Senior Manager Quality Assurance

Requisition ID 2024-14393

Posting Date 22 minutes ago (4/26/2024 5:45 PM)

Job Location(s) Bloomington IN United States

Travel Less than 10%

Position Type Full Time

Company Cook Inc - Bloomington

Category Quality

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 with
minimal 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.

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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.