Senior Design Quality Engineer

Senior Design Quality Engineer

Location: Marlton, NJ

# of Openings: 1

Hope is Here!

Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM™ , which is delivered by the company’s Optimizer® Smart System. CCM is a first‑of‑a‑kind, proprietary, life‑changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany.

There are 64 million patients struggling with Heart Failure worldwide. When these patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road are extremely invasive. CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients.

This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy.

The Sr QE is responsible for providing QA leadership and partnering with product development with planning, coordinating, and managing the quality assurance (QA) activities associated with PD projects to ensure compliance to internal and external requirements during the development and commercialization of new products and changes for existing products.

Responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes and documentation in compliance with domestic and international regulatory/quality requirements.

• Design Control expert who works with product development engineering to ensure proper completion of required documentation for design control phases according to the design controls SOP.
• Quality lead on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
• Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs.
• Complete Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
• Author and maintain all risk documentation required for Impulse Dynamics products.
• Complete and own design history file verifications during and at the end of each design control phase.
• Review and approve all external Engineering Change Orders provided by the contract manufacturer and assess risk documentation.
• Assist in writing, updating and/or reviewing of procedures and other quality assurance related technical data forms and quality documents.
• Adhere to QMS requirements outlined in procedures and work instructions.
• Review validation protocols and reports for GMP compliance.
• Assist in carrying out internal quality audits on company systems and documentation.
• Authors non-conformance reports and corrective actions.
• Perform investigations of non-conformances, customer complaints and corrective actions.
• Ensures the timely and effective follow-up of all identified or assigned quality issues.
• Assists in the maintenance of the Quality Management System.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Provide training and support for quality system processes and quality engineering practices.
• Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, 21 CFR part 820, 21 CFR part 812, MDSAP and MDR.
• Develop, conduct, and document Quality design engineering procedures, including equipment repair, failure analysis, and product deployment.
• Write clear and detailed technical reports and procedures in English.

• BS in Engineering or Life Science Field.
• 10 years of experience in medical device industry or regulated environment…