Job Title: Quality Engineer
Location: Newton, MA
About Us:
Are you passionate about ensuring the highest quality standards in medical devices that make a real difference in patient care? We are a leading innovator in wound care trauma pads, we are dedicated to delivering advanced solutions that enhance patient outcomes and support healthcare professionals in their critical work. We are currently seeking a meticulous and driven Quality Engineer to join our team. In this role, you will play a crucial part in maintaining the exceptional quality of our Class 2 medical devices, overseeing the entire lifecycle from product development through to supply chain and manufacturing. If you are an experienced quality engineer with a strong background in medical devices, and thrive in a collaborative and dynamic environment, we invite you to be part of our mission to advance wound care technology and improve patient lives.
Position Overview:
We are looking for a skilled and proactive Quality Engineer to join our team in Newton, MA. The ideal candidate will have at least 2 years of experience in quality engineering with a solid background in supply chain management, manufacturing processes, vendor/supplier relations, and product development. This role is pivotal in ensuring our medical devices meet stringent quality standards and regulatory requirements.
Key Responsibilities:
- Supplier and Vendor Management:
- Develop and maintain strong relationships with suppliers and vendors to ensure the quality of incoming materials and components.
- Conduct supplier audits and assessments to evaluate performance and compliance with quality standards.
- Work with suppliers to address quality issues, resolve non-conformances, and implement corrective actions.
- Quality Assurance and Compliance:
- Implement and manage quality control processes to ensure compliance with industry regulations and standards, including FDA and ISO 13485.
- Perform regular inspections and audits of manufacturing processes to ensure adherence to quality specifications.
- Develop, review, and approve quality documentation, including inspection reports, non-conformance reports, and corrective and preventive action (CAPA) plans.
- Product Development Support:
- Collaborate with the product development team to provide quality input during the design and development phases.
- Ensure design controls are implemented and followed, including risk management activities such as FMEA and Design Verification and Validation (V&V).
- Review and approve design changes and product specifications to maintain product quality and compliance.
- Continuous Improvement:
- Drive initiatives for continuous improvement in quality management systems and manufacturing processes.
- Analyze quality data and performance metrics to identify areas for improvement and implement effective solutions.
- Cross-Functional Collaboration:
- Work closely with manufacturing teams to resolve quality issues and enhance production processes.
- Partner with engineering, regulatory, and other departments to ensure quality objectives are met and projects are completed successfully.
Qualifications:
- Education:
- Bachelor's degree in Engineering, Quality Assurance, or a related field.
- Experience:
- At least 2 years of experience as a Quality Engineer, preferably in the medical device industry.
- Proven experience with supply chain management, manufacturing processes, vendor/supplier relations, and product development.
- Skills:
- Strong understanding of quality management systems and regulatory requirements.
- Proficiency in quality tools and methodologies, including statistical analysis, root cause analysis, and problem-solving techniques.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal teams and external suppliers.
- Strong organizational skills and attention to detail with the ability to manage multiple tasks and projects simultaneously.
- Certifications:
- ASQ Certified Quality Engineer (CQE) or similar certification is a plus but not required.
What We Offer:
- Competitive salary and comprehensive benefits package
- Opportunities for professional growth and development
- A dynamic and supportive work environment
- The chance to contribute to meaningful advancements in medical technology
