Senior Quality System Engineer - Medical Device #8997

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
Understand 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.
• Possessing the ability to 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.

Benefits

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.