Provide Quality Engineering support in the development, manufacture, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives. Establish and maintain quality assurance standards that adhere to ISO 13485, FDA and other governmental regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Develop quality documentation including validation protocols, reports, specifications, test methods, sample plans, and related procedures. Define and specify the implementation, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products.
Provide Quality Engineering support for the development of new products including:
oversight and participation in the design control system
oversight and participation in the risk management system including the development of Use Risk, Design Risk, and Process Risk documentation.
the development and execution of Quality Plans.
Work with the Manufacturing, Clinical Affairs, and R&D functions to coordinate pilot production of new products and product improvement projects.
Establish and maintain quality assurance procedures, provide assistance and education on the use of the procedures and ensure compliance and timeliness of the output records of the procedures.
Provide tracking systems and support for:
CAPAs: assisting process owners with planning and implementing CAPAs in a timely manner and performing effectiveness checks on implemented CAPAs.
Non-Conforming Material Reports (NCMRs): plan and implement NCMRs in a timely manner and ensure accurate disposition of related materials.
Complaints: process and resolve complaints in a timely manner and ensure accurate disposition of related materials.
Manage supplier quality relationships: working with suppliers, develop Quality Agreements and corrective action plans to correct any process failings and drive improvement in quality. Assist in supplier qualification activities including supplier on-site audit and evaluation.
Maintain Quality Systems, including pre-production QA procedures, pre-clinical testing programs, and post-production Quality System compliance in coordination with Doc Control, Clinical, Operations and R&D functions.
Review DCOs involving product or process changes to ensure consistency with company procedures and quality system requirements.
Assess DCOs, complaints, CAPAs and NCMRs for new or revised risks as part of the oversight of the risk management system.
Assist Regulatory Affairs department in preparation of regulatory submissions.
Complete projects (including product enhancements) in an aggressive manner consistent with corporate objectives. Determine day-to-day tasks in accordance with overall project plan.
Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Company products.
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/MDD regulations.
Maintain a professional, credible image with key physicians, consultants, suppliers, and co-workers.
Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.
Actively promote and support the company’s Management Review process.
Inform responsible personnel of concerns involving product quality.
Perform job functions in a safe and effective manner
Other duties as assigned
Bachelor’s Degree in Mechanical, Electrical, or Biomedical Engineering or equivalent field and 8+ years related medical device experience
Strong skills with Microsoft Office products, including Word and Excel
Working knowledge of statistical techniques
Prior experience required in cardiovascular device design control
Prior experience required in creating risk management documents, including analyzing and summarizing device risk for risk management report
Ability to communicate effectively, both orally and in writing, with all organizational levels
Strong attention to detail and ability to function in a fast-paced dynamic environment
About Imperative Care
Imperative Care is singularly dedicated to finding meaningful answers to unsolved problems in stroke. Founded by experienced healthcare leaders and clinical advisors, Imperative Care understands the vast and urgent needs in stroke. Our focus is on medical technology designed to expedite and improve the effectiveness of treatment, giving patients a chance for optimal recovery.
When stroke happens, time is measured in seconds, not days or years. How we use it makes all the difference. The time is now. It’s crucial, vital, urgent. Stroke care can’t wait, that’s why we are Imperative Care.