Job Description
Job Title: Associate Quality Engineer
Location: Neptune, NJ
Job Summary: This role operates under broad supervision and is responsible for independently setting basic quality standards for both in-process activities while leading efforts to develop methods for testing, sampling, and training. The Associate Quality Engineer will evaluate production processes, recommend improvements, qualify and conduct vendor management, generate and maintain Device Master Records (DMRs), product specifications, design control files, and CE technical files.
Major Responsibilities:
- Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products meet quality standards.
- Design experiments to understand sources of variation affecting products and processes. Apply statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
- Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
- Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.
- Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
- Build appropriate product documentation (e.g., Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
- Coordinate product testing with internal and external laboratories as required.
- Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
- Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
Education:
- Bachelor's degree in Engineering, Science, Math, or other related technical field.
Work Experience:
- At least 2 years of experience in Quality or Engineering.
Knowledge / Skills / Abilities:
- Ability to develop ways of accomplishing goals with little or no supervision.
- Strong time management skills to prioritize, organize, and track details to meet project deadlines.
- Proficiency in problem-solving and reaching successful solutions through mathematical or systematic operations.
- Proficiency in MS Office Suite products (Word, Excel, PowerPoint, Outlook).
- Intermediate Skill Level in Microsoft Excel (e.g., conditional formatting, tables, formulas, charting).
- Working knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO13485).
- Position requires up to 15% travel.
Preferred Job Requirements:
- At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
