Senior Manager Quality Assurance - Cook Group

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.

 - 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.

- 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.