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Quality Engineer - Medical Device - Southborough, MA - Southborough Massachusetts
Company: Michael Page
Location: Southborough, Massachusetts
Posted On: 01/19/2025
The Quality Engineer (medical device manufacturing) will lead efforts to ensure product compliance with medical device regulations and quality standards, focusing on design controls, risk management, and validation activities at our Southborough, MA facility. They will collaborate cross-functionally to drive continuous improvement, resolve complex quality issues, and support the seamless transition from design to manufacturing.Client DetailsMy client is a global leader in advanced engineering, prototyping, and product development, specializing in micro-manufacturing for the medical device and diagnostics industries. They collaborate with customers to bring innovative medical technologies to market quickly, focusing on improving patient care worldwide. The company provides end-to-end support, from initial concept design and prototyping to validation and high-volume manufacturing, offering flexible solutions tailored to each project's needs.Their product development team is guided by principles of quality, speed, and collaboration, leveraging deep expertise in minimally invasive devices, delivery systems, and advanced therapeutic solutions. With a focus on cutting-edge manufacturing processes and regulatory compliance, my client excels at overcoming technical challenges at every stage of development. They emphasize early consideration of manufacturability and cost-efficiency to ensure seamless product launches.Operating in a fast-paced, innovation-driven environment, my client values urgency, teamwork, and continuous improvement. They are committed to fostering a culture of inclusion, respect, and integrity, ensuring employees are engaged and motivated. By maintaining a strategic focus on high-growth markets and leveraging a highly skilled team, they provide their customers with advanced solutions designed to improve healthcare outcomes globally.DescriptionThe Quality Engineer, Medical Device Manufacturing, will: - Apply advanced Quality Engineering techniques to daily tasks, ensuring adherence to relevant regulations, standards, and industry best practices.
- Lead or participate in design reviews, ensuring comprehensive application of design controls per ISO 13485:2016 and QSR 21 CFR 820.
- Collaborate with cross-functional teams, including NPI, product development, process, and assembly, to drive quality initiatives and ensure successful project outcomes.
- Conduct and oversee root cause investigations, utilizing problem-solving tools to implement and assess corrective and preventive actions.
- Develop and maintain process and production controls, including quality control plans, statistical process controls, and inspection sampling techniques.
- Lead risk management and mitigation activities, developing innovative tools and approaches for detection systems and validations.
- Prepare, review, and implement protocols, reports, deviations, and validations for quality assurance.
- Act as the lead QE for product development projects, providing strategic input and technical expertise.
- Mentor team members and collaborate with senior quality leaders to enhance organizational Quality Engineering capabilities.
- Serve as a subject matter expert in routine quality areas, providing guidance on compliance and regulatory requirements.
- Partner with senior technical leaders to identify opportunities for technical innovation and business improvement.
- Support catheter design and manufacturing
- Act as a second-in-command to the Quality Manager or Director, providing leadership support as needed.
- Onsite at our Southborough, MA facility Profile
- 2-7 years of experience in Quality Engineering within the medical device industry.
- Proven expertise in developing design solutions and supporting product design processes.
- Familiarity with ISO 13485 standards and regulatory requirements for medical devices.
- Experience with Class II and III medical devices preferred.
- Strong technical skills with a focus on problem-solving and process improvement.
- Green Belt certification preferred; Lean/Six Sigma knowledge is a plus.
- Hands-on experience with catheter design or manufacturing is a significant advantage.
- Bachelor's degree in a technical field preferred, but exceptional candidates without a degree will be considered.
- Ability to collaborate with cross-functional teams to ensure quality standards are met.
- Knowledge of risk management and validation processes for medical devices.
- Demonstrated success in identifying and implementing quality improvements.
- Excellent communication and documentation skills to support audits and regulatory compliance.
- Local to Southborough, MA Apply today for consideration of your resume within 48 business hours!Apply today for reviewal of your application and resume within 48 business hours! Job Offer
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