Quality Engineer with experience supporting medical device manufacturing operations, ensuring compliance with FDA, ISO 13485, and customer quality requirements through robust quality systems, risk management, and continuous improvement initiatives. Skilled in root cause analysis, validation activities, CAPA management, and cross-functional collaboration to drive product quality, regulatory compliance, and patient safety.
Client Details
Our client is an innovative and growing medical device manufacturer dedicated to developing high-quality products that improve patient outcomes and support healthcare professionals around the world. Operating in a highly regulated environment, the organization is committed to maintaining the highest standards of quality, regulatory compliance, and continuous improvement while investing in advanced technologies and manufacturing capabilities.
The company has built a strong reputation for its collaborative culture, where employees are empowered to contribute ideas, solve complex challenges, and make a meaningful impact on both the business and the patients who rely on its products. With a growing product portfolio, a financially stable foundation, and a commitment to professional development, this organization offers an excellent opportunity for individuals seeking a rewarding career in the medical device industry.
Description
- Support the launch and ongoing manufacturing of medical devices by identifying, qualifying, and partnering with primarily domestic contract manufacturing suppliers to ensure quality, delivery, and performance objectives are achieved.
- Provide production support for existing product lines through supplier selection, supplier relationship management, and execution of corrective and preventive actions (CAPA).
- Collaborate with Product Development teams to provide quality and manufacturing expertise throughout the product development lifecycle while ensuring compliance with Design Control requirements.
- Contribute to product designs by supporting Design for Reliability (DFR), Design for Manufacturability (DFM), Design for Inspection (DFI), regulatory compliance, and cost optimization initiatives.
- Lead root cause investigations related to manufacturing issues, nonconformances, customer complaints, and field feedback, implementing effective corrective actions to prevent recurrence.
- Develop, coordinate, and execute process validation and production qualification activities to ensure manufacturing processes consistently meet quality and regulatory standards.
- Support strategic manufacturing initiatives, including the evaluation and implementation of new internal manufacturing capabilities and the potential transition of outsourced processes to in-house production.
- Design and execute testing protocols, validation studies, and product evaluations to verify functionality and demonstrate compliance with applicable regulatory and quality requirements.
- Prepare, maintain, and manage Design Control documentation, including design history files, risk management documentation, validation records, and other product development deliverables.
- Work cross-functionally with Engineering, Quality, Regulatory Affairs, Operations, and Supply Chain teams to drive product quality, process improvement, and operational excellence.
- Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and internal quality management system procedures.
- Support continuous improvement initiatives focused on product quality, supplier performance, manufacturing efficiency, and customer satisfaction.
Profile
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related engineering discipline.
- 5-7 years of experience in Manufacturing Engineering, Quality Engineering, or a closely related technical role.
- Prior experience within the medical device industry, including at least 3 years supporting FDA-regulated products, is highly preferred.
- Working knowledge of quality management systems and regulatory standards, including ISO 13485, ISO 9001, and FDA Quality System Regulations.
- Demonstrated success leading cross-functional projects from development through commercialization, including manufacturing implementation and ongoing production support.
- Strong project management skills with experience managing project schedules, deliverables, resources, and budget considerations.
- Understanding of Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), and associated design control documentation requirements.
- Proven ability to work effectively in a fast-paced, collaborative environment where flexibility, initiative, and teamwork are critical to success.
- Self-motivated professional with strong communication, organizational, and problem-solving abilities.
- Desire to play a key role within a growing organization where individual contributions have a direct impact on business and product success.
Job Offer
- Salary up to $130,000
- 15% Bonus
- 3 weeks PTO
- Medical
- Dental
- Vision
- More!
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.