QA Engineer- On Site

Sartorius • Yauco, PR

4d • Onsite

About The Position

The Quality Engineer will be responsible for ensuring that every product produced by a company meets the desired quality standards. The holder of this position will support the implementation of quality initiatives and continuous improvement to support the company Quality Management System. Plans, schedules, executes, and communicates all items regarding Quality issues, events, complaints, validations, and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards ad applicable regulations. What you will accomplish together with us - Main Responsibilities & Tasks: Support the development and maintenance of the QMS for the company to ensure compliance with ISO 9001 standard and regulations Develop risk assessment and mitigation plans through FMEA’s and other risk assessment tools Support manufacturing engineer in process validations, process control, process training programs, process improvement, risk management, and software validations and control. Review and/or develop protocols for validation, evaluate data, and write reports – including generation statistical analysis of quality data Perform studies on new equipment to establish control points and proper settings. Serve as resource for problem identification, improvement, and resolution. Prepare reports to evaluate effectiveness of quality systems. Provide support for customer representatives in regard to quality issues. Work cooperatively in a team environment to reach common results and goals. Work with suppliers to resolve or improve quality issues and to implement effective corrective action. Develop and maintain quality standards and requirements for development and design projects.

Requirements

• Bachelor's degree in engineering
• Minimum of 5 years of experience in quality (preferable in medical device or pharmaceutical industry)
• Experience in validation lifecycle
• Knowledge in continuous improvement techniques
• Detail oriented with strong organizational skills
• Excellent written and interpersonal communication skills
• Ability to read, write and speak fluent English
• Experience with Quality Risk Management, Problem Solving and Statistical Analysis, and Project Management Tools.

Nice To Haves

• ASQ Quality Engineer Certification (CQE) is preferable

Responsibilities

• Support the development and maintenance of the QMS for the company to ensure compliance with ISO 9001 standard and regulations
• Develop risk assessment and mitigation plans through FMEA’s and other risk assessment tools
• Support manufacturing engineer in process validations, process control, process training programs, process improvement, risk management, and software validations and control.
• Review and/or develop protocols for validation, evaluate data, and write reports – including generation statistical analysis of quality data
• Perform studies on new equipment to establish control points and proper settings.
• Serve as resource for problem identification, improvement, and resolution.
• Prepare reports to evaluate effectiveness of quality systems.
• Provide support for customer representatives in regard to quality issues.
• Work cooperatively in a team environment to reach common results and goals.
• Work with suppliers to resolve or improve quality issues and to implement effective corrective action.
• Develop and maintain quality standards and requirements for development and design projects.

Benefits

• Paid vacation and sick leave
• 14 paid holidays annually
• Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees. We offer an open-office concept, a spacious outdoor area, conference areas and a development center.
• Medical, Dental and Vision insurance along with Company Retirement Plan
• On-site cafeteria and coffee shop
• On-site occupational health offices including Laboratory Services & Doctors

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees