Area Quality Assurance ManagerAre you looking for a challenging and rewarding opportunity in a fast-paced environment? Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business? Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?
Job DescriptionManage 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. Expert regarding selected governmental regulations for the site(s). Proactive liaison with customer for quality assurance across site(s). Leads a defined group of Quality Assurance resources and key initiatives, disseminating regulatory and corporate policy changes. Develops and implements policy and procedures for sites under their responsibility. Develop, manage, and oversee site quality managers/coordinators. Leads global and cross-sector QA initiatives. Develops and implements 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
- Manages 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
- 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
Required Education and Experience- Bachelor's degree in a related field or 5+ years relevant work experience, required
- Graduate's degree in related field, preferred
- 5+ years of relevant experience in a regulated environment such as FDA, Health Canada, etc. Regulated experience required for regulated sites, required
- 3+ years of supervisory or management experience (preferably supervising/managing a quality system in a complex/matrix organization), preferred
- Certification related to quality control (RAC, Six-Sigma, etc.), preferred
Our Organization has a business casual environment and focuses on teamwork, associate development, training, and continuous improvement. We offer competitive wages, excellent affordable insurance benefits (including health, dental, vision and life), 401K plan, paid vacation and holidays.
Our Organization is an equal opportunity employer.
