Job Description

Job Title: Quality Assurance Manager

Location: Ansonia, CT

Salary Range: $95,000 – $115,000

Type: Direct Hire

POSITION SUMMARY

The Quality Assurance Manager is responsible for the establishment, planning, and execution of all aspects of the Quality Management System. Provides direction and management of the quality group. Ensures all applicable regulatory quality requirements have been established and maintains compliance. The Quality Assurance Manager is self-driven and ready to learn new technologies.

This position reports to: Director of Operations

ESSENTIAL FUNCTIONS -

• Functions as Management Representative. Leads internal and external audits.
• Develops, modifies, applies and maintains quality management system and strategic planning for additional business opportunities.
• Managing team members
• Collaborates with internal and external customers to ensure quality standards are compliant and satisfactory for objectives.
• Development of quality key metrics, reports, and analysis of the quality management system.
• Work with manufacturing, customers and suppliers to ensure quality requirements are communicated and maintained.
• Represents the QA function and acts as a liaison to customers.
• Provides leadership and guidance to the Quality group.
• May on occasion be required to assist with various quality department needs as they arise.

JOB QUALIFICATIONS

• Extensive understanding of ISO 9001 & FDA cGMP requirements.
• Must be proficient in English (communication & reading).
• Solid understanding of quality requirements for a medical device contract manufacturer.
• Effective organization skills.
• Strong oral and written communication, computer literacy, organizational skills and effective leadership qualities.
• Ability to multi-task and foster an environment of teamwork and collaboration.
• Attentive and detail orientated.

EDUCATION REQUIREMENTS

• BS in Engineering, Physics, Mathematics, Science, or equivalent experience.

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