QLTY & RELIABILITY ENGINEER I

Job Overview

Functional Job Family Description
A Quality & Reliability Engineer uses their engineering skills to assist in issues related to the Quality of the product. This job also involves leveraging advanced technical skills to resolve issues related to the product to meet quality goals. 

Nature and Overall Purpose of the Role Performed

• Apply problem-solving techniques
• Working align requirements in the medical industry (FDA regulations), ISO 13485.
• Apply statistical tools, quality, and reliability software to resolve problems.
• Apply spreadsheets, databases, and Process Control Monitoring (SPC).
• Leadership in process improvement, Six Sigma, product and process qualification, new product transfer and validation.

KEY RESPONSIBILITIES& TASKS

• Responsibility Includes the Following Tasks
• Investigate complaints from customers, suppliers, and internal non-conformities.
• Perform root cause analysis; determine corrective action and verify effectiveness.
• Ensure corrective and preventive action plans are developed and implemented.
• Assist in the coordination of quality system continuous improvement processes.
• Create and modify current procedures and instructions.
• Develop and analyze statistical data and specifications to determine standards and establish product quality expectations.
• Validate new equipment or processes. (IQ / OQ / PQ)
• Conduct training for personnel to ensure compliance with company procedures.
• Prepare and present technical and program information for team members and management.
• Perform internal audits within the company to ensure compliance with applicable standards / regulatory requirements and organizations and ISO.
• Communicate issues or events discovered during major quality assurance audits and recommend process improvements to the quality manager.
• Prepare reports to communicate quality metrics.
• Maintain a working knowledge of government and industry quality assurance standards.
• Function as a resource for Quality System related issues.
• Ensure a high level of internal and external customer service.
• Make improvements that minimize the cost of quality, specifically rejects, failures and any production defects.
• Work with production in solving production and quality related problems.
• Follow all duties as assigned by the Quality Manager.
• Must be able to support departments such as Doc Control, Training, Calibrations, Incoming, Environmental Monitoring, Pest Control and Methods.

What your background should look like:

Job Specific Knowledge, Skills and Abilities

• Knowledge - NCMRs/CARs/CAPA, Customer Complaints per million, Quantity of returned product (RMAs), DPPM, DLPM.
• Skills- Skills are the proficiency to perform a certain task.
• Abilities- Abilities are an underlying, enduring trait useful for performing tasks (oral comprehension, understanding information and ideas).
• Language: Bilingual English (Intermediate)/ Spanish.
• Knowledge of Microsoft Office.
• Knowledge of problem-solving techniques.
• Knowledge of working requirements in the medical industry (FDA regulations).
• Excellent knowledge of Creganna Quality System.
• Knowledge of statistical tools, quality and reliability software.
• Knowledge of spreadsheets, databases, and Process Control Monitoring (SPC).
• Experience in process improvement, Six Sigma, product and process qualification and validation.
• Detailed knowledge of FDA, GMP and ISO 13485.
• Experience in new product transfer.
• Knowledge of measuring instruments, sampling plans.

Education
Bachelor’s Degree with a scientific or engineering emphasis.

Professional Training & Certifications
CQE/CSSBB certification desirable.

Competencies