Quality Manager: QMS Leader (FDA/ISO)

American Society for Quality; Clayton (NC); On-site; USD 110,000 - 138,000; Full time

Benefits offered by this job

Health coverage

Dental coverage

Vision coverage

401(k) plan

Job summary

TekniPlex in Clayton, NC is hiring a Quality Manager to oversee the site Quality Management System (QMS) and foster a strong quality culture. The role delivers consistent quality performance and mentors the QA team, aligning with customer and regulatory requirements including 21 CFR 820 and ISO 13485.

The position offers an annual salary range of $110,000 to $138,000, commensurate with experience, plus a comprehensive benefits program.

Qualifications

• Bachelor's degree in Engineering, Business with a strong quality focus, or similar degree.
• 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.
• Excellent communication and interpersonal skills.
• Six Sigma Black Belt certification preferred.
• Exceptional attention to detail.
• 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 implementation and follow-up.
• Develop, review, and approve QA documentation for site activities.
• Report QMS performance to top management and drive improvements.
• Build relationships with customers through proactive quality communication.
• Ensure manufacturing processes meet customer, FDA 21 CFR 820, and ISO 13485 requirements.
• Lead internal and external audits including notified body inspections.
• Lead and mentor a high-performing QA team aligned with business objectives.
• Promote a quality culture and continuous process improvements across the business.
• Manage the Quality budget with site management to achieve objectives.

Skills

QMS Leadership

Quality Assurance

Audit Leadership

CAPA Management

Regulatory Knowledge

Statistical Analysis

Communication

Education

Bachelor's degree in Engineering or Business

Tools

Statistical software

Job description

TekniPlex in Clayton, NC is hiring a Quality Manager to oversee the site Quality Management System (QMS) and foster a strong quality culture. The role delivers consistent quality performance and mentors the QA team, aligning with customer and regulatory requirements including 21 CFR 820 and ISO 13485.

The position offers an annual salary range of $110,000 to $138,000, commensurate with experience, plus a comprehensive benefits program.