Job Information
Skytron LLC Director of Quality (Hybrid) in Grand Rapids, Michigan
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