Supervisor, Quality Assurance

Supervisor, Quality Assurance

Key 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:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

• 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

Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply.The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.