Quality Engineer II Job Description Template
Our company is looking for a Quality Engineer II to join our team.
Responsibilities:
- Conducts root cause and corrective action investigations for quality failures, including those occurring in supplier and in-house processes;
- Auditor of process;
- Regulatory reviews;
- Support external partners in the remediation of Design History Files;
- Lead and support EU MDR work streams;
- Collaborate with internal and external partners to fulfill company EU MDR objectives;
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements;
- Support Design Reviews, Technical Reviews, and Peer Reviews;
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment;
- Review engineering documents to ensure quality and compliance;
- Provide status updates and estimates and track new features or bug fix statuses with team lead;
- Design and develop frameworks and tools using PHP, JAVA, Perl and bash/shell scripting;
- Implement statistical techniques to determine sample sizes and levels of confidence;
- Interprets existing and emerging regulations, standards and guidance documents;
- Drives innovation and integration of new technologies into projects and activities in the software quality assurance organization.
Requirements:
- Knowledge of analytical techniques, problem solving and statistical analysis;
- Experience in medical device field in a manufacturing support role a plus;
- Good verbal and written communication skills;
- Knowledge of international Standards: ISO 9000, ISO 13485, ISO 14971;
- Working knowledge of EU MDR Requirements and Regulations for medical devices;
- Bachelor’s degree in an Engineering or STEM field or related education and experience;
- Ability to work effectively in cross-functional teams;
- Knowledge of human anatomy/physiology a plus;
- Exposure to FMEA;
- Six Sigma Certified Green or Black Belt;
- Implement statistical techniques to determine sample sizes and levels of confidence;
- Able to work independently as well as in a team setting;
- PC literacy in word processing, spreadsheets, presentation applications, and database management;
- 1-2 years of experience in coding in Perl/PHP/C# with relational database MySQL/MariaDB;
- Familiarity with Medical Device Capital Equipment is preferred.