Area Quality Assurance Manager

About the role

Are 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?

Responsibilities

• 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 expert regarding selected governmental regulations for the site(s)
• Act as proactive liaison with customer 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 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

• Bachelors Degree or equivalent 4 years work experience, required
• 7+ years of relevant experience in a regulated environment, required
• 5+ years of supervisory or management experience, required

Qualifications & Skills

• Certification related to quality control (RAC, Six-Sigma, etc.), preferred
• 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