Reports To: Von Kramer (Robert Shanley site DOO)
Direct Reports: 11
The Primary purpose of this Job is responsibility for the planning, and management of a quality Engineering group, which includes Quality Engineering and Quality Assurance.
- Adheres to Viant’s Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S.Food and Drug Administration (FDA) regulations, Company Policies and operating procedures, and other regulatory requirements.
- Maintains safe and ethical business practices and adheres to Viant’s Quality Policy.
- Manages the Quality Team to meet Site and Organizational goals and customer expectations.
- Collaborates with cross functional organizations to facilitate successful execution of lean initiatives, production plans and Product Development Process.
- Oversees, coordinates and supports the Continuous Improvements, Control Plans and Validations using statistical methods relevant to manufacturing processes.
- Provides ongoing metrics communications and support to Plant Management toward attainment of objectives.
- Performs corrective & preventive actions so that customers’ needs are satisfied; directs, plans and implements a comprehensive quality system designed to improve product quality and increase customer satisfaction.
- Performs and coordinates qualification activities in accordance with internal process and to the intent of the Master Validation Process.
- Manages subordinates in a manner that fosters a self-directed and collaborative team approach.
- Coordinates and Provides training and mentoring for Quality Improvements to enhance Associates skills, increase awareness and Improve productivity.
- Assists in the development and Implementation of Quality Objectives.
- Participates and/or Leads Project teams for implementation of Site Quality Objectives.
- Supports and Maintains alignment of site QMS Documents with QMS Enterprise Policies.
- Serves as the Management Representative for All Quality
- Interviews, hires, and establishes training plans for direct reports. Provides leadership regarding development of individuals’’ goals and mentoring of the group.
- Performs other functions as required.
- Bachelor’s Degree in a related Field
- 5-8 years of related experience in Quality and personnel/supervisory positions
- ISO 13485, 21 CFR 820, ASQ Certifications
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.