Qualty Management System Specialist

Quality Management System Specialist

We currently have an opportunity for a Quality Management System Specialist to provide quality system and compliance oversight for contract medical device manufacturing. The position is responsible to maintain an established quality management system. A successful candidate will partner with all areas of the company and host and facilitate effective third-party audits.

Responsibilities

• Manage a compliant and effective Quality System focused on ISO 13485 and 21 CFR820.
• Management of quality sub systems of CAPA management, management control, production and process controls, auditing, and training.
• Monitor and report to management on the quality system health and facility inspection readiness.
• Conduct internal and external audits, as needed.
• Drive quality system initiatives and improvement activities while partnering cross functionally with production unit.
• Provide leadership and guidance to escalate quality system issues to all levels of the organization.
• Assist with the implementation and maintenance of an MRP system and quality module.

Qualifications, Required:

• Bachelor’s degree.
• Excellent interpersonal skills with strong written and oral communication skills.
• Strong analytical and problem-solving skills.
• Good project management skills.
• Meticulously detail orientated.
  • Proficient in Microsoft Office.

Qualifications, Desired:

• Experience in a regulated quality management system, such as medical device manufacturing, automotive manufacturing, etc.
• Lead Auditor certification (i.e. ISO 9001/13485 lead auditor).
• Experience dealing directly with FDA inspectors and other regulators during quality system audits.
• Experience with ISO 13485 and 21 CFR Part 820.

Compensation dependent on education and experience.