Boyd Industries, Inc. Clearwater, Florida www.boydindustries.com

Help Ensure Quality, Compliance, and Continuous Improvement in Medical Device Manufacturing

Boyd Industries is a leading U.S. manufacturer of innovative dental and medical equipment, proudly designing and manufacturing products that support healthcare professionals across North America. Our commitment to quality, safety, and regulatory excellence is central to everything we do.

We are seeking a highly motivated Quality Assurance Engineer to join our Quality team in Clearwater, Florida. This position plays a critical role in maintaining and improving our Quality Management System (QMS), supporting regulatory compliance, driving continuous improvement initiatives, and ensuring that our products meet the highest standards of quality and performance.

If you are passionate about quality systems, root cause analysis, process improvement, and working in a regulated manufacturing environment, we invite you to join our team.

Position Summary

The Quality Assurance Engineer is responsible for supporting and maintaining Boyd's Quality Management System in compliance with ISO 13485, FDA Medical Device Regulations, and other applicable international standards. This role partners closely with Operations, Engineering, Supply Chain, and Manufacturing teams to ensure product quality, regulatory compliance, and continuous process improvement throughout the organization. This position also serves as a key resource during audits, inspections, validations, and corrective action activities. 

Key Responsibilities

Quality Management System & Compliance

• Support the implementation, maintenance, and continuous improvement of Boyd's ISO 13485-compliant Quality Management System.
• Assist with internal audits, supplier audits, management reviews, and regulatory inspections.
• Support compliance activities related to FDA, ISO, Intertek/ETL, and other applicable regulatory requirements.
• Maintain quality documentation and ensure proper document control practices.

Product Quality & Process Improvement

• Develop and implement inspection methods and quality processes across manufacturing operations.
• Analyze quality data and performance metrics to identify trends, risks, and improvement opportunities.
• Utilize statistical analysis tools and methodologies to evaluate process capability and product performance.
• Lead root cause investigations and corrective/preventive action (CAPA) activities.

Supplier Quality & Validation

• Partner with suppliers to establish and maintain quality requirements.
• Support supplier qualification, audits, and corrective action activities.
• Assist in planning and executing IQ, OQ, and PQ validations for products and manufacturing processes.
• Participate in component and product approval activities.

Cross-Functional Leadership

• Serve as a Quality representative on new product development and continuous improvement teams.
• Participate in Materials Review Board (MRB) activities and nonconformance investigations.
• Collaborate with Engineering, Operations, and Supply Chain teams to resolve quality concerns and improve manufacturing performance.
• Support risk management and regulatory documentation efforts.

Qualifications

Education & Experience

• Bachelor's degree in Engineering, Quality Engineering, Industrial Engineering, Mechanical Engineering, Electrical Engineering, or a related technical discipline preferred.
• Equivalent combination of education and relevant quality experience will be considered.
• Experience working within an ISO-regulated manufacturing environment.
• Experience with CAPA systems, auditing, and root cause analysis preferred.
• Medical device, healthcare manufacturing, or regulated industry experience is highly desirable. 

Knowledge & Skills

• Working knowledge of ISO 13485 and FDA Quality System Regulations.
• Experience with formal problem-solving methodologies and continuous improvement tools.
• Knowledge of Lean Manufacturing, Six Sigma, Kaizen, or related process improvement methodologies.
• Strong analytical and statistical problem-solving skills.
• Experience using measurement and inspection equipment, including gauges, calipers, and electrical testing equipment.
• Proficiency with Microsoft Excel, Word, and related business visualization software.
• Excellent verbal and written communication skills.
• Strong organizational skills and attention to detail.

What Makes You Successful

You are:

• Detail-oriented and data-driven.
• A collaborative team player who can work effectively across departments.
• Comfortable managing multiple priorities in a fast-paced manufacturing environment.
• Passionate about quality, process improvement, and customer satisfaction.
• Committed to maintaining the highest standards of compliance and integrity.

Why Boyd Industries?

At Boyd Industries, you'll join a team dedicated to delivering exceptional products that support healthcare providers and improve patient experiences. We offer the opportunity to work in a collaborative environment where quality, innovation, and continuous improvement are valued and rewarded.

Benefits Include:

• Competitive salary
• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off and holidays
• Career development opportunities
• Stable, growing U.S.-based manufacturing company

Apply Today

If you're ready to make an impact and help drive quality excellence in a regulated manufacturing environment, we'd like to hear from you.

Boyd Industries is an Equal Opportunity Employer and maintains a drug-free workplace.