Quality Manager - Medical Device Manufacturing

Are you a Quality Manager in the Medical Device Manufacturing Industry? Are you local to Greenville, NC or want to relocate to the Carolina's? Do you have ISO 13485 and a strong root cause analysis background? Do you want to drive compliance and continuous improvement? If so, please read on and apply to the Quality Manager - Medical Device Manufacturing job based near Greenville, NC.

Client Details

We are partnered with a growing Medical Device Manufacturing company in their search to add a Quality Manager to the team due to growth. The Quality Manager - Medical Device Manufacturing is responsible for overseeing and managing the quality assurance and quality control functions within a medical device manufacturing environment. This role ensures that products meet all applicable regulatory requirements (e.g., FDA, ISO 13485) and internal quality standards, while driving continuous improvement initiatives across the organization.

Description

The Quality Manager - Medical Device Manufacturing will be responsible for the following:

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
• Lead internal and external audits, including FDA inspections and ISO certification audits.
• Manage CAPA (Corrective and Preventive Action) processes, non-conformance investigations, and root cause analyses.
• Oversee document control, change management, and training programs related to quality.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Regulatory, R&D) to ensure quality is built into product design and manufacturing processes.
• Monitor and report on key quality metrics, trends, and performance indicators.
• Ensure supplier quality through audits, assessments, and incoming inspection protocols.
• Support risk management activities including FMEA and hazard analysis.
• Lead and mentor quality assurance and quality control staff.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.

Profile

The ideal Quality Manager - Medical Device Manufacturing will have the following qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
• Minimum 5 years of experience in quality management within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and other relevant standards.
• Experience with QMS software and tools (e.g., MasterControl, Greenlight Guru).
• Strong compliance leadership and customer-facing confidence.
• Hands-on with validations, RCA, CAPA, and QMS development.
• Comfortable working in a lean team and wearing multiple hats.
• Familiarity with tools like Minitab and e-QMS platforms.
• Certified Quality Auditor (CQA), Six Sigma, or similar certifications are a plus.
• Excellent communication, leadership, and problem-solving skills.

Job Offer

The successful Quality Manager - Medical Device Manufacturing will be rewarded with the following:

• Competitive salary ranging from $100,000 to $140,000 depending on experience
• Sign on Bonus
• Relocation Package if required
• Performance-based bonus opportunities.
• PTO
• 401K Match
• Health, Dental, Vision
• Opportunities for career growth within the Medical Device Manufacturing Industry
• A supportive work environment that values quality and innovation.

If you are ready to take your career to the next level as a Quality Manager - Medical Device Manufacturing in Greenville, NC, this is your chance. Apply today to join a team that values excellence and growth!

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.