Job Details

Join a team that improves patient outcomes, through innovative and flexible solutions to the acute care market! When you work for Skytron, you get so much more than a job, including:

• Comprehensive benefits package, beginning on day one
• Annual Bonus
• Paid vacation, personal days, and holidays
• 401(k) and Profit sharing
• Tuition reimbursement program
• Onsite gym
• Family-owned and operated business

As the Director of Quality, you will:

• Develop, implement, and audit Skytron quality systems in support of domestic and international sales and development activities
• Ensure Skytron's business operations adhere to applicable regulatory requirements and standards, including: ISO 13485, GMP, and FDA
• Foster an organizational culture knowledgeable of and committed to quality standards. This includes directing and participating in continuous improvement initiatives across the organization, to improve Skytron's products and systems
• Manage Skytron's internal investigation process related to incoming complaints
• Execute effective programs for CAPAS, field corrections, recalls, SCARs, and audits; ensuring non-conforming products are adequately isolated and contained from customer use
• Employ independent market surveillance and direct the QA organization to monitor performance and feedback from customers
• Keep abreast of regulatory change, advising leadership of business implications
• Lead and execute effective training throughout the organization, related to quality standards and change management
• Direct Skytron's Quality department, including management of day-to-day activities, coaching and developing employees, development and execution of departmental goals, and preparation of the departmental budget
• Prepare quality-related product and process reports through the collection, analysis, and summarizing of relevant data

For success in this role, you will:

• Capably handle required administrative functions
• Verify work to ensure accurate results, requiring minimal rework
• Follow work instructions, procedures, safety guidelines, and company policies
• Give customer needs priority, responding quickly to concerns and demonstrating a desire to assist others
• Meet productivity standards
• Be detail-oriented and possess the ability to multi-task, work under pressure, and meet deadlines
• Listen to others, expressing ideas with tact and clarity
• Be internally motivated and work well with minimal supervision
• Devise workable solutions or consult with secondary resources to devise solutions
• Have a Bachelor's degree in a relevant field and 5+ years of experience and demonstrated success leading quality initiatives and team members in a highly regulated field
• Have direct experience working with FDA and other health authorities (Highly preferred)
• Be knowledgeable of US cGMP regulations, industry best practices, EU MDD, and ISO 13485 requirements (Highly preferred)
• Be proficient in Microsoft Office, including: Word, Excel, and PowerPoint