Quality Manager

Responsible for managing all quality functions related to product and process quality, including quality engineering, supplier product quality, metrology, calibration, inspection, document control, environmental monitoring, and process validation.       MAIN JOB RESPONSIBILITIES: Ensures direct and indirect reports follow all GMPs and SOPs as defined by Viant Medical’s policies and procedures to ensure that the FDA, ISO regulations and Viant Medical’s quality standards are met Provides Quality Leadership for the Quality Department and works with the Quality Director to align and prioritize KPIs, Goals, and Strategic Initiatives Manages, motivates, and develops the Quality staff to achieve organizational goals, including defining and communicating goals/expectations and assignments, conducting performance reviews, monitoring results, coaching, and holding the team accountable Responsible for leading in a manner which follows Viant Medical’s values ; Customer Oriented, Integrity, Servant Leadership, Own It, Be Agile, and Teamwork Responsible for the management and continuous improvement of the Quality system and acting as the Site Management representative Oversee Internal/external Audit, CAPA Program, Environmental monitoring program, Calibration program Conducts and coordinates training of all personnel in product quality competencies Supports interactions with customer and suppliers on all quality matters while building and maintaining strong relationships Responsible for collaborating with other department Managers to solve problems and acts as a technical resource for problem solving Interfaces with customers by: Reviewing product quality requirements and specifications Developing quality plans for new products Developing Master Validation Plans for product and process qualification Completing all required phases of product qualification prior to release to production Managing change during life of the products Participating in Drumbeat Meetings Coordinating validation activities during internal or external product transfers Coordinating investigations, responses, and communication of customer complaints Measures, monitors, and reports on key product quality metrics Drives lean culture and continuous quality improvement through quality policy and quality initiatives Participates and supports strategic planning for quality system improvement Develops capital and expense budgets to support business plans Other duties as assigned POSITION REQUIREMENTS: Education: 4-year degree in Engineering or related technical field preferred   Job Experience: 5 years of experience in Quality Assurance. Minimum of 2 years of management experience; related experience in a manufacturing environment within a regulated marketplace, primarily Medical Device preferred.  Strong technical quality skills including experience as a quality engineer. Excellent leadership and communication skills with experience being a change agent and managing change. Operational Excellence/Six Sigma/Lean training and experience is desirable. Preferred Skills/Qualifications: FDA/ ISO/ GMP knowledge base Experience as the lead in handling an FDA inspection; and as the official FDA Correspondent is desirable. Product design and development Quality Engineering (validation, sustaining, change management, root cause analysis, qualification) Strong knowledge in principles, training, and experience in Quality Engineering, such as: Metrology, GDT, MSA, Calibration Statistics, sampling, and SPC Personnel development and management experience in a high-volume production facility in the medical device industry