Quality Manager: QMS Leader for MedTech & CAPA

TekniPlex; Clayton (NC); On-site; USD 110,000 - 138,000; Full time

Benefits offered by this job

Medical Coverage

Prescription Drug Coverage

Vision Coverage

Health Savings Account (HSA)

Flexible Spending Account (FSA)

401(k) Retirement Savings Plan

Daily Pay

Job summary

TekniPlex in Clayton, NC seeks a Quality Manager to lead the site Quality Management System, promote a strong Quality culture, and coach the QA team to excellence. The role emphasizes regulatory compliance (FDA 21 CFR 820, ISO 13485) and continuous improvement to safeguard patient outcomes and product integrity.

With a salary range of $110,000 to $138,000, relocation assistance is available for qualified candidates.

Qualifications

• Bachelor’s degree in engineering or quality focus or similar field.
• 10+ years of quality assurance management experience.
• Experience with FDA 21 CFR Part 820 and ISO 13485 environments is required.
• Strong understanding of statistics, quality equipment, instruments and processes.
• Good communication and interpersonal skills using tact and diplomacy.
• Exceptional attention to detail.
• Must be self-directed with leadership qualities.
• Ability to travel up to 15%.

Responsibilities

• Act as the site Management representative for the QMS and ensure effectiveness per 13485:2016.
• Manage customer complaints, non-conforming material, CAPA and follow-up activities.
• Develop, review, and approve QA documentation related to site activities.
• Report QMS performance to top management and recommend improvements.
• Build customer relationships through proactive communication on quality requirements and changes.
• Verify or validate manufacturing processes per customer requirements, FDA and ISO standards.
• Lead internal and external audit programs, including notified body inspections.
• Build and mentor a high-performing Quality team and align with business objectives.
• Champion a culture of customer focus and continuous quality improvements.
• Manage the Quality budget with site leadership to meet objectives.

Skills

Quality management

Regulatory compliance

Leadership

Communication

Attention to detail

Statistics

Travel readiness

Education

Bachelor’s degree in engineering or quality

Job description

TekniPlex in Clayton, NC seeks a Quality Manager to lead the site Quality Management System, promote a strong Quality culture, and coach the QA team to excellence. The role emphasizes regulatory compliance (FDA 21 CFR 820, ISO 13485) and continuous improvement to safeguard patient outcomes and product integrity.

With a salary range of $110,000 to $138,000, relocation assistance is available for qualified candidates.