paycor
Senior Quality Engineer
Impulse Dynamics
Marlton, USA
Full-time
Mid Level
Onsite
USD 120000-130000 yearly
Discovered 1 weeks ago
Free
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- Design Control Coordinator: works with product development engineering to ensure proper completion of required documentation for design control phases according to the design controls SOP. Ensures the electronic Design History File is maintained.
- Represent Quality 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. Coordinates with Regulatory Affairs and Product Development to identify the full range of standards for all intended regions for distribution.
- Ensure completion of Risk Management activities for new and/or modified products and processes, which include risk assessment, occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required. Collaborate with risk management team members from regulatory, product development, and medical affairs/clinical to ensure robust and realistic documents are created.
- Author and maintain all risk documentation required for Impulse Dynamics products.
- Complete design history file verifications at the end of each design control phase.
- Support the creation and maintenance of Device Master Records (Technical Dossier) for all products.
- Review and approve all external Engineering Change Orders provided by the contract manufacturer and assess risk documentation.
- Review and approve all internal change orders 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 and alignment with industry best practices.
- Assist in carrying out internal quality audits on company systems and documentation.
- Authors non-conformance reports and initiates and owns corrective actions.
- Perform investigations using recognized quality engineering tools 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.
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