Manager, Quality Assurance and Quality Control

The Quality Assurance and Quality Control Manager serves on a cross functional team, ensuring the adequacy, suitability and compliance of specified Quality Management System processes and Quality Engineering decisions. Manages day-to-day quality operations and provides leadership and direction to the functional team.

- 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.
- Actively assure operational observance to compliance obligations to include, regulatory, contractual, and SOP driven requirements.
- Actively look for ways to improve quality processes and procedures.
- Attend, present and provide data for meetings to include project updates and reviews.
- Participate in hiring, interviewing and onboarding process of new hires.
- Responsible for managing quality engineers and quality control personnel.
- Responsible for performance management and annual reviews of direct reports.
- Authorization of weekly time sheets.
- Develop plans to evaluate improvement projects.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, ISO 11135 and other applicable regulatory requirements.

- 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.

- Bachelor's degree in Engineering or Life Science or experience of such kind and amount as to provide a comparable background.
- Minimum 5 years experience in a regulated industry, preferably in a medical manufacturing environment and EtO sterilization.
- Minimum 3 years experience working with quality management system.
- Minimum 3 years experience working with EtO sterilization (ISO 11135)
- Previous leadership experience.
- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects.

Physical Requirements:

• Works under general office environment conditions

• Utilizes close visual acuity for working with computers and equipment

• Frequently required to stand, walk, and hear

• Occasionally required to lift up to 20 pounds