Area Quality Assurance Manager

This candidate must be local to one of the account sites (Houston TX, Austin TX, Kansas City MO, Huntsville AL, DeKalb IL, Aurora IL, Springfield NE, Beaver Dam WI, Montgomery AL, Rayville LA, Rosemount MN, Temple TX) and be available for extensive travel to the other site locations.

About the role

Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across multiple sites. Confirm requests for quality support from the site and communicate policies and procedures. Serve as an expert regarding selected governmental regulations for the site(s). Act as a proactive liaison with customers for quality assurance across site(s). Lead a defined group of Quality Assurance resources and key initiatives, disseminating regulatory and corporate policy changes. Develop and implement policy and procedures for sites under their responsibility.

• Develop, manage, and oversee site quality managers/coordinators.
• Lead global and cross-sector QA initiatives.
• Develop and implement processes for regulated hardware, equipment, and software systems (validated as applicable).
• Oversee the maintenance and continuous improvement of the overall quality system for multiple sites or multiple customers within a site, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
• Oversee the licenses, permits, and registrations process.
• Manage the validation process (as applicable) at a sector or network level and associated change control processes.
• Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to regulatory guidelines, the contract, and customer requirements; reporting the results to executive management.
• Work in coordination with continuous improvement team to focus/direct continuous improvement activities/workshops.
• Review and provide recommendations on regulatory, customer, and 3rd party audits.
• Review and identify trends within the quality assurance metrics for the organization.
• Serve as the primary customer contact for QA-related issues/initiatives as needed.
• Develop, distribute, and maintain regular management reports. Compile executive-level reports as required.
• Ensure site suppliers are assessed. Coordinate, prepare, receive, and act on audits.

Requirements

• Bachelor’s Degree or equivalent.
• 4+ years of work experience, required.
• 7+ years of relevant experience in a regulated environment, required.
• 5+ years of supervisory or management experience, required.
• Certification related to quality control (RAC, Six-Sigma, etc.), preferred.

Skills

• People management.
• Sufficient computer application experience.
• Strong written and verbal communication.
• Data analysis experience.
• Training and facilitation skills.
• Self-management.
• Problem-solving.
• Project management.
• Presenting.
• Report creation.
• Solution execution.
• Process development.
• People development.
• Quality program start-up experience.
• Standards development.
• Customer management.

Pay

National salary range of $85,000–$150,000.

Benefits

• Medical, Dental, Vision, Prescription.
• Discounted Stock Purchase.
• General Bonus Plan.
• Generous PTO policy.