Senior Quality System Engineer - Medical Device #9557

About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

Work Model: This is a part-time role for 3 months. Work preference will be on-site at the MA facility. 

About the Role
This role serves as a quality representative to improve awareness, visibility and communication of quality initiatives. The position provides focused quality engineering support for new product development, operations and quality systems while maintaining an unwavering commitment to patient safety and product quality.

What You'll Do

• Develop, establish and maintain quality engineering methodologies, systems and practices that meet customer and regulatory requirements.
• Serve as the quality representative to promote awareness, visibility and communication of quality initiatives across departmental, functional, site, divisional and corporate teams.
• Identify and implement effective process control systems that support product development, process qualification and ongoing manufacturing performance.
• Support the implementation of quality assurance activities, process controls and CAPA systems to meet or exceed internal and external requirements.
• Partner with cross-functional teams to support quality disciplines, decisions and best practices throughout the product life cycle.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues.
• Support the development and execution of efficient business systems that proactively identify and resolve quality concerns.
• Maintain compliance with documented quality system processes and procedures, demonstrating a primary commitment to patient safety and product quality.
• Support continuous improvement initiatives that enhance product quality, compliance and operational effectiveness.
• Organize, analyze and present quality data to influence decision-making with internal stakeholders.

What We Look For

• Strong knowledge of ISO 9001 requirements.
• Deep knowledge of quality assurance terminology, methods and tools
• Excellent analytical, problem-solving and decision-making skills.
• Demonstrated knowledge of quality best practices, version-control procedures and defect management processes.
• Professional certification such as Six Sigma, CQE (certified quality engineer) or CQA (certified quality auditor)
• Superb computer proficiency, including database management.
• Bachelor’s degree (or equivalent) in engineering or related field
• Understanding of agile/scrum methodology and how QA functions within it.
• Ability to communicate in more than one language

ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future.  At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.