Supervisor, Quality Assurance

Responsibilities

• Lead, supervise, and develop a team of Quality Technicians responsible for supporting manufacturing operations, supplier quality activities, and quality system processes.
• Foster and sustain a culture of quality that prioritizes patient safety, product reliability, regulatory compliance, and continuous improvement.
• Partner with cross-functional teams to ensure quality is embedded in all aspects of daily work.
• Establish clear performance expectations, conduct performance evaluations, provide mentoring and training, and support employee development to build a high-performing quality organization.
• Ensure inspection, testing, product release, and other quality assurance activities are performed in accordance with approved procedures, specifications, and regulatory requirements.
• Lead quality support activities on the manufacturing floor, including the management and disposition of nonconforming materials, investigations, complaint reviews, corrective and preventive actions (CAPA), and change control activities.
• Partner with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and Operations to ensure product quality, compliance, and business objectives are achieved.
• Monitor and analyze quality performance metrics utilizing statistical methods and data-driven decision making to identify trends, drive continuous improvement, and support the ConMed Quality Management System.
• Manage quality technician resources and priorities to effectively support production schedules while maintaining compliance with quality system requirements.
• Communicate and escalate significant quality issues, ensuring risks to product quality, compliance, delivery, and customer satisfaction are addressed in a timely manner.
• Provide training, consultation, and guidance on quality systems, quality engineering principles, statistical techniques, problem-solving methodologies, and investigation tools.
• Support continuous improvement initiatives through effective application of root cause analysis, risk-based decision making, and quality system processes.

Qualifications

• Bachelor’s degree in engineering, science, quality, or related field
• 4 years of experience in quality assurance within a regulated industry (medical devices preferred).
• Candidates without a bachelor’s degree must have at least 10 years’ experience and relevant education or certifications in areas such as Quality Assurance.

Preferred Qualifications

• Highly skilled in risk management, nonconformance management, inspection methodology, and root cause investigation.
• Demonstrated proficiency with ERP platforms as well as expertise in using electronic quality management systems (eQMS).
• Supervisory or team leadership experience, including project participation and key influencing roles.
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971 and risk-based decision making.

Benefits

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses