REPORTS TO: Senior Manager, Quality Assurance
The primary purpose of this job is to coordinate activities and provide daily direction to a significant size or volume of quality technicians and other team members to ensure that quality requirements, performance goals and improvement objectives are achieved. In addition, this role will develop process improvements and identify deficiencies in processes or systems that enable the department to execute at a more accurate and efficient level. Additionally, this role will work with production to ensure that efforts are aligned and will manage the day-to-day processes around performance management and attendance for each individual in the department.
- Adheres to Viant’s Core Beliefs 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.
- Manage daily performance and attendance of Quality Assurance and Calibration Technicians in the inspection and final release of sub-component parts and finished goods. Provide work direction and guidance throughout the shift on issues relating to Quality and schedule attainment.
- Manage daily performance and attendance of Calibration Technicians in the calibration of gages used for product inspection and process control.
- Provide guidance and direction to associates who interact with third party calibration suppliers and customers in timely calibration of gages to the appropriate standard and usage.
- Review all product non-conformances and determine necessary corrective actions.
- Monitor/track QA/QC department metrics and develop continuous improvement plans that drive site Gs&Os.
- Oversee incoming/in-process sub-components and finished goods.
- Support Quality Engineering and Manufacturing Engineering in the resolution of non-conforming materials.
- Supervises Associates in a manner that fosters a safe work environment and self-directed team approach.
- Promotes an atmosphere of diversity, open communication and trust, affording opportunities for training and growth.
- Identifies, arranges and/or provides training to ensure a safe, efficient, quality work environment with focus on continuous improvement through Lean manufacturing principles.
- Facilitates communication, coordination and conflict resolution within and among work groups.
- Provides leadership to Associates in all areas including: hiring, performance management, coaching, counseling, and corrective actions.
- Performs other functions as required.
The successful candidate will
- Manage the throughput and quality of product inspections and release performed by Quality Technicians, preventing impact to On Time Delivery while maintaining Quality System requirements.
- Manage the throughput and quality of gage and process calibrations, preventing disruption to Operations while maintaining Quality System requirements.
- Work closely with Manufacturing and Quality Engineers to investigate nonconforming material and prevent reoccurrence.
- Lead to optimal performance through individual and team development, communication, and delivering results.
- Manage the purchase of new and replacement gages as requested from the Calibration Technician or Engineering department. Submit purchase order requisitions to purchasing through Oracle.
- Able to demonstrate strong problem solving skills. The candidate will be able to evaluate and assess issues at hand, develop plans for corrections and implementation as well as defined methods for maintenance and monitoring.
- Associates or Bachelor’s degree in technical field required. In lieu of a degree a qualified candidate must have 5-7 years of equivalent experience.
- At least 3-5 years of prior QA/QC Supervisory experience in a manufacturing environment preferred; medical device experience preferred.
- Working knowledge and application of ISO 13485 and FDA 21 CFR Part 820 quality system requirements.Inclusive of Good Manufacturing Practices and Good Documentation Practices. Auditing training and experience preferred.
- Ability to interpret drawings, strong understanding of Geometric dimensioning and tolerancing (GD&T), as well as applicable gauging, and inspection methods.
- Standard knowledge of Microsoft Office Suite, Access database and Oracle ERP experience preferred.
- The use of statistical software, preferably MiniTab.
- Minimal travel required. Occasional visit to third party calibration suppliers or local customers possible.
- Knowledgeable in the use of Coordinate and Vision Measurement devices like CMM, OGP, and Keyence. Required understanding of the proper use of standard measurement gaging like Optical Comparator, Mics, Calipers, Height Gages, and hard gaging.
- Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
- Close vision, distance vision, and color vision
- Standard Manufacturing Environment conditions apply. Gloves required in the handling of cleaned and passivated product, safety glasses required while in manufacturing areas, and ear protection to be used for prolonged work in areas that require.
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.