Director of Quality (Direct hire) / Atlanta metro

Summary The Director of Quality provides strategy and direction to ensure all processes for Quality Assurance and Quality Engineering are established, implemented and maintained in accordance with applicable standards, and is responsible for ensuring that the business meets or exceeds the expectations of customers and other stakeholders in these areas. Essential Functions
  • Marietta site leader of Quality function
  • Leads the quality strategy
  • Lead the ISO 9001/13485 based quality programs to ensure effective implementation of quality systems, continuous improvement efforts, and promotion of a quality/compliance culture
  • Provides leadership in product quality problem solving resolution efforts across the organization
  • Act as the primary authority for compliance actions such as product or service corrective actions or internal audits
  • Serve as chair of the Quality Management Representative deputy to facilitate review and decision-making based on the operation of quality systems and quality metrics
  • As needed, provide leadership on quality matters during mergers and acquisitions
  • Act as the primary authority for internal quality compliance matters
  • Familiarity with product development, manufacturing and supply chain life cycles an advantage
  • Oversee, manage and lead the Quality Assurance and Quality Engineering team by providing guidance and priorities.
  • Gather and trend all Quality metrics.
  • Leadership:  Demonstrated success in effectively leading a quality organization, including a history of building a cohesive organization working collaboratively across all parts of the organization.
  • Strategic orientation:  The successful candidate will have a strategic and broad approach and will have proven his/her ability to establish strategy and to translate it into an effective, long-term action plan.  He/she will have a track record of anticipating potential problems through effective analysis and proactively seeking solutions.
  • Collaboration/relationship building:  The successful candidate will be assertive, poised and professional and have demonstrated the ability to build bridges and influence upward.  He/she will be someone who builds trust through consistency and a high level of integrity.
  • Critical thinking/problem solving:  The successful candidate will have demonstrated the ability to take steps to understand and resolve problems and to move rapidly to resolution.  We seek a professional who prioritizes critical issues and is driven by results.
  • Results Orientation: Drive to achieve results and goals in the short and long term.
  • Sense of Urgency:  Ability to push high priority projects through in a fast paced environment.
  • High Intellect: Conceptual, strategic; ability to probe into specifics when necessary. Analytical and fact-based, but able to draw on intuition, knowledge and experience.  Ability to prioritize the most relevant from all other issues. Creative and independent thinker. Open minded.
  • Adaptive to change: Ability to adapt to work effectively in an environment of change, uncertainty, and ambiguity. Must be able to make pragmatic decisions in a timely fashion.
  • Continuous Improvement: Recognized leadership in developing and managing a continuous improvement culture
Education and Experience
  • Bachelor’s degree in related science or technical engineering discipline
  • At least 7 to 10 years of progressive Quality (in ISO 9001/13485, CEIVDD and US FDA (Class 2 or higher) requirements) experience in a medical device or scientific instrument company
  • Experience leading activities and personnel within Quality Assurance including Process QA, Software QA, Hardware QA, Supplier QA for ISO 13485 and FDA 21 CFR part 11
  • Has successfully lead product quality problem resolution cross functional teams
  • Strong people management skills and ability to work cross functionally
  • Strong understanding of Quality concepts in a manufacturing environment such as statistical analysis, cpk, ppk and gage R&R.
  • Proficiency with precision measuring tools.
  • Strong knowledge of calibration and ability to read blue prints.
Please submit MS Word resume to HR@isg-resources.com

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