Senior Quality System Engineer - Medical Device at Enhanced Compliance Inc.

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.

About the Role

• Interpret, build upon and comply with the company’s quality assurance standards
• Maintain the complaint, nonconformity and corrective action procedures using records and tracking systems, including root-cause analysis
• Document quality assurance activities utilizing internal reporting processes and expectations
• Understanding of quality assurance requirements/activities associated with internal reporting and audit activities
• Identify training needs and ensure companywide participation
• Pursue continuing education in new solutions, technologies and skill

What You'll Do

• Plan, execute and oversee Quality Management System metrics.
• Monitor Customer Complaints, ensuring proper tracking and documentation
• Maintain Supplier Quality files
• Support internal and external audits
• Provide training and support to the organization focusing on systems, policies, procedures and core processes.
• Partner with colleagues to resolve concerns, non-conformities, etc.

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.