QUALITY MANAGER Position Available In Iredell, North Carolina

QUALITY MANAGER

Structure Medical

LLC – 4.4

Mooresville, NC Job Details Full-time Estimated:

$90.6K – $114K a year 14 hours ago Qualifications CGMP Management 5 years Engineering GMP Microsoft Office Analysis skills Supervising experience Quality assurance Bachelor’s degree Senior level Communication skills

ISO 13485 FDA

regulations Full Job Description The Quality Manager is responsible for overseeing and directing the quality assurance and quality control functions to ensure that products meet required specifications and comply with all regulatory standards. This role is critical in maintaining the integrity of the manufacturing process and ensuring that all products meet medical industry standards, including

FDA, ISO

13485, and customer-specific requirements.

Key Responsibilities:

Quality System Oversight:

Maintain and continually improve the Quality Management System (QMS) in accordance with

ISO 13485, FDA 21 CFR

Part 820, and other applicable regulatory standards.

Regulatory Compliance:

Ensure compliance with all applicable quality and regulatory requirements related to medical device manufacturing.

Audit Management:

Lead internal and external audits, including FDA inspections, ISO certification audits, and customer audits. Prepare audit responses and implement corrective actions as needed.

Document Control:

Oversee document control processes, including SOPs, work instructions, quality records, and change control.

CAPA and Nonconformance Management:

Manage the Corrective and Preventive Action (CAPA) system, nonconformance investigations, root cause analysis, and implement effective solutions.

Supplier Quality Management:

Evaluate and monitor supplier performance. Support supplier audits and implement supplier improvement initiatives.

Product Quality Assurance:

Oversee in-process and final product inspection activities. Ensure product quality meets customer and regulatory specifications.

Training & Development:

Develop and deliver training related to quality system requirements, regulatory compliance, and continuous improvement.

Customer Interface:

Act as the primary quality contact for customers, addressing complaints, quality concerns, and improvement initiatives.

Metrics & Reporting:

Establish and monitor key performance indicators (KPIs) for quality performance. Report metrics to leadership and recommend process improvements.

Qualifications:

Education & Experience:

Bachelor’s degree in Engineering, Life Sciences, or a related field required. Minimum 5 years of experience in quality assurance within a medical device or medical contract manufacturing environment. Supervisory or management experience preferred.

Knowledge, Skills, and Abilities:

Strong knowledge of

ISO 13485, FDA QSR

(21 CFR Part 820), and GMP regulations. Experience managing audits and interfacing with regulatory bodies. Proficiency in risk management tools (e.g., FMEA, HACCP) and root cause analysis techniques. Excellent written and verbal communication skills. Strong analytical and problem-solving abilities. Proficient with Microsoft Office and QMS software platforms. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.