Specialty Appliances Orthodontic Laboratory is the industry leader in orthodontic/dental technology due to agility, speed, and cutting-edge technology. We work in a fast-paced and highly evolving market that requires adaptability while maintaining the highest level of quality and ensuring compliance to FDA 21 CFR 820, ISO 13485 and MDSAP certification. As a Class I and Class II medical device manufacturer, this role is an integral part of our day-to-day operations. Currently we have operations in Georgia, Virginia, Oklahoma, Massachusetts, and offshore vendors in India, and expect to expand through M&A. Behind all this success is an amazing group of people who are passionate about our vision, which is being The Helping Hand for the Perfect Smile.
We are seeking a collaborative, people-focused leader to oversee our quality management system (QMS) and ensure compliance with FDA 21 CFR 820, ISO 13485, and MDSAP standards. You will work hand-in-hand with Engineering, Operations, Customer Service and other executive team members to drive continuous improvement and solve complex challenges in a dynamic environment.
If you share in our passion for teamwork, problem-solving, and a vision for excellence, let's talk about a rewarding career at Specialty Appliances!
About Us
Established in 1981, we have grown to become the nation's largest orthodontic laboratory and a significant player in the dental lab industry. Our mission is to positively impact lives by providing high-quality dental solutions. With a consistent compound annual growth rate exceeding 10%, achieved through strategic mergers, acquisitions, and organic expansion, we are poised for accelerated growth in the coming years. Supported by Reynolda Equity Partners, we embrace an entrepreneurial spirit, striving to double our sales and triple our EBITDA. We are on a journey to ensure that every step we take is purposeful and precise, reflecting our commitment to excellence and meaningful impact.
In this role, you will...
Lead QMS development and maintenance, ensuring compliance with FDA, ISO 13485 and MDSAP requirements.
Oversee quality and regulatory compliance across multiple sites.
Partner with cross-functional teams to implement quality and regulatory strategies across all sites.
Serve as Management Representative.
Drive continuous improvement initiatives, leveraging problem-solving skills to enhance processes.
Prepare and lead regulatory audits.
Mentor and develop high-performing teams throughout the organization.
Use tools such as SPC and implement strategies while collaborating with other departments.
Collaborate with Engineering in development and validation of new products.
Collaborate with Operations in development and validation of new processes.
Collaborate with Customer Service in improving customer satisfaction.
Collaborate with Purchasing in Supplier Management activities.
Use ISO 14971 principles to drive improvement through the organization.
Participate in strategic decision-making as related to quality and regulatory compliance.
Collaborate with the executive leadership team in finding the best solutions and strategies for the company's future.
Develop and manage quality and regulatory department budget, aligning resources with compliance and improvement goals.
Fulfill Management Representative role for the company.
Manage quality assurance and quality control personnel on a day-to-day basis.
Safeguard and protect confidentiality of company and patient information as defined by the company's Confidentiality Agreement.
In this role, you'll need to have...
Degree in Engineering and/or MBA
10+ years' experience managing quality and regulatory compliance, multisite preferred.
Minimum of 7 to 10 years managerial experience.
Background in medical device manufacturing required.
Success with leading a site through an FDA, ISO 13485 and MDSAP audits.
Management Representative experience with FDA, ISO13485 and MDSAP certification
Excellent understanding of QMS within the medical device industry
Merger & Acquisition experience preferred.
Strong computer skills including quality control applications, spreadsheets, and LMS.
A strong leader with the ability to manage and provide direction for employees at all levels.
Strong decision-making, problem-solving, and time-management skills.
Ability to sit and/or stand for extended periods of time depending upon task being performed.
An intelligent and articulate individual who can relate to people at all levels of an organization and possesses excellent communication skills.
Familiar with SPC and other quality tools.
Ability to read, write, speak, and understand English.
What We Offer
Competitive Salary
Medical, Dental, and Vision Insurance
Short-term and Long-term Disability, Life and AD&D Insurance