<p>At Viant, we partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world.</p> <p>As Quality Manager, 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.</p> <p>Essential duties and responsibilities:</p> <ul> <li>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, ISO Standards, Company policies and operating procedures, and other regulatory requirements. </li><li>Maintains safe and ethical business practices and adheres to Viant's Quality Policy. </li><li>Manages the Quality Team to meet Site & Organizational goals and customer expectations. </li><li>Collaborates with cross functional organizations to facilitate successful execution of lean initiatives, production plans and Product Development Process. </li><li>Oversees, coordinates and supports the Continuous Improvements, Control Plans, Quality Plans and Validations using statistical methods relevant to manufacturing processes. </li><li>Provides ongoing metrics communications and support to Plant Management toward attainment of objectives. Performs corrective & preventive actions so that the customers' needs are satisfied; directs, plans and implements a comprehensive quality system designed to improve product quality and </li><li>increase customer satisfaction. </li><li>Performs and coordinates qualification activities in accordance with internal processes and to the intent of the Master Validation Process. </li><li>Manages subordinates in a manner that fosters a self-directed and collaborative team approach. </li><li>Coordinates and provides training and mentoring for Quality Improvements to enhance Associate skills, increase awareness and improve productivity. </li><li>Assists in the development and implementation of Quality Objectives. </li><li>Participates and/or Leads Project Teams for the implementation of Enterprise and Site Quality Objectives. </li><li>Supports and Maintains alignment of Site QMS Documents with QMS Enterprise Policies. </li><li>Serves as the Management Representative. </li><li>Hosts internal and external audits including Notified Body (ISO), Customer and FDA. </li><li>Interviews, hires, and establishes training plans for direct reports. </li><li>Provides leadership regarding development of individuals' goals and mentoring of the group. </li><li>Performs other functions as required. </li></ul> <p>The successful candidate will possess:</p> <ul> <li>5+ years of experience in a regulated industry (Medical - Aerospace- Automotive) </li><li>5+ years of Quality Managment leadership experience </li><li>Bachelor's degree required; Master's degree in Engineering, Quality Management, or a related field preferred. </li><li>Extensive experience with FDA, ISO-13485, ISO-9001 and other relevant regulations. </li><li>Experience within a contract or OEM manufacturing (Preferred) </li><li>Proven track record of successful regulatory audits and compliance. </li><li>Demonstrated experience leading and interacting with customers and suppliers. </li><li>Demonstrated experience leading high-functioning teams and driving continuous improvement using Lean Six Sigma methodologies. </li><li>Exceptional communication and interpersonal skills. </li><li>Strong problem-solving abilities and decision-making skills. </li><li>Results-oriented with a track record of achieving key performance indicators (KPIs). </li></ul> <p>Benefits:</p> <ul> <li>Medical, dental, and vision benefits-effective date of hire! </li><li>Company-paid life insurance and disability benefits </li><li>Generous Paid time off and 10 paid Holidays </li><li>401k Plan with Company Match </li><li>Tuition Reimbursement </li><li>Voluntary Universal Life and Long-Term Care </li><li>Voluntary Legal Plan </li><li>Pet Insurance </li><li>Home Ownership Program </li></ul> <p>#INDHP</p>