Quality Manager - Medical Device or Pharma Required

Quality Manager Location: Colonial Heights, Virginia area Lead a tenured team and drive cultural transformation in a stable, growing plant that offers excellent profit sharing and a beach‑access lifestyle. Benefits: Competitive salary plus 401k, profit sharing, bonus potential, and free product giveaways. Up to 45–50 hour work week with flexible scheduling, all just an hour away from the coast. Private office, supportive management group. Medical benefits day one, paid holidays, personal days, vacation, 401K, profit sharing, stock purchase plan, and bonus potential. Excellent work/life balance and beachside location. Responsibilities: Monitor and improve the quality management system. Oversee and ensure regulatory and legal compliance, including leading and guiding direct reports. Manage and lead root cause analysis and ensure countermeasures are completed. Responsible for validation of new and existing products. Communicate plant quality KPIs, goals and initiatives to plant management and corporate representatives. Prepare for and execute internal and external quality audits. Drive and achieve quality continuous improvement initiatives, including cost savings goals for the plant. Interact with plant and corporate teams on quality projects. Develop and maintain key quality performance indicators. Lead and participate in cross‑functional teams related to plant quality. Partner with R&D for on‑site trial activities. Execute and improve quality training, including quality orientation training. Complete non‑routine quality projects and higher level crisis management. Assist with vendor qualification. Other tasks as assigned by management. Qualifications and Requirements: Minimum of a Bachelor's degree, ideally in a science or technical field. At least five years in a similar manufacturing quality leadership position. Experience supervising others. Experience overseeing quality in medical device or pharmaceutical manufacturing. Experience working in GMP or FDA regulated environments. Working knowledge of micro‑organisms. Strong background with root cause analysis and CAPA. Strong quality auditing background. Experience with statistical analysis. Experience working in established QMS environments, e.g., ISO 13485. Proficiency in Microsoft Word, Excel, PowerPoint and Outlook. Preferred but not required: Quality certifications. Lean and/or Six Sigma. ERP experience. Power BI. Validation experience. Why work for this organization: Strong tenure in the plant, averaging 20 years among all team members. Excellent benefits, including 401K, profit sharing and bonus potential. Excellent work/life balance, averaging 45–50 hours per week with flexibility for appointments/activities. Excellent location; only an hour to the beach. You will have your own office and oversee a tenured team. Work with a solid and collaborative management team, working hard to improve the culture daily. FREE product giveaways; save money on items that you use regularly. Apply now. #J-18808-Ljbffr Keystone Distinction Group