Skytron
Director of Quality (Hybrid)
Skytron, Grand Rapids, Michigan, us, 49528
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.
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.