Director of Quality (Hybrid) - Skytron LLC

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

If you need assistance with any aspect of the application process or would like to request a paper application, please contact Skytron's Human Resources Department at 800.759.8766.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.