Our client is seeking a Quality Engineer to support our client's manufacturing facility in Norristown, PA. Under broad supervision, this role independently sets basic quality standards for both in-process and finished product testing, while leading efforts to develop methods for testing, sampling, and training. The Quality Engineer evaluates production processes, recommends improvements, qualifies and manages vendors, and generates and maintains DMRs, product specifications, design control files, and CE technical files.
Responsibilities
- Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
- Design experiments to understand sources of variation affecting products and processes; apply statistical process control (SPC) methods for analyzing data to evaluate current processes 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 510(k) 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).
Qualifications
- Bachelor's degree in Engineering, Science, Math, or another related technical field.
- At least 2 years of experience in Quality or Engineering.
- Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
- Experience using time management skills to prioritize, organize, and track details in order to meet deadlines across multiple projects.
- Experience problem-solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic approaches.
- Experience using 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, ISO 13485).
- At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role is a plus.
Location
Employee Type
Compensation & Benefits
- Hourly rate $45-$55
- Medical and dental insurance
- Paid vacation time
- 401(k) after 90 days
About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
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