Sr. Quality Engineer

About the role

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger. The Sr. Quality Engineer is a key contributing member of the Quality Assurance team, working to implement and maintain the Quality Management System (QMS) to ensure that the activities of the company are performed in compliance with the QMS and applicable regulatory requirements. The individual also serves as a key member of product development teams to perform activities related to design, development, manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. This person also works to identify deficiencies in quality system and device performance and recommend and implement corrective and preventive actions. This role reports to the Director of Quality Assurance and Regulatory Affairs. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Responsible for assuring product quality, safety and effectiveness, and conduct failure investigations of customer complaints, as required.
• Ensure project teams are utilizing Resonetics Quality Systems and appropriate regulations and industry standards throughout the product development process.
• Collaborate with the development engineering team(s) to create and/or update documentation to support Design Controls.
• Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
• Conduct risk assessments of the design to determine ability to function as intended.
• Responsible for completion of risk analysis and mitigating actions.
• Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and supplier audits, product release, document control, design control process and design history files (DHF), device master records, etc.
• As a lead Quality Engineer on projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for clinical, pilot production and scale-up builds.
• Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information.
• Auditing and qualification of new suppliers may be required.
• Help create and implement and maintain product/process specifications, standards, and procedures to support QMS implementation and documentation. This involves writing and revising documents as necessary.
• Maintain QMS to ensure full compliance to all quality and regulatory requirements.
• Manage the Document Control process and ensure all steps of this process are performed.
• Provide statistically valid sampling plans when required.
• Work closely with engineering in understanding, developing and executing statistically designed experiments.
• Manage Training program, including maintenance of training records and monitoring training compliance.
• Procure and maintain external standards.
• Develop incoming, in-process, and final inspection and