Quality Engineer

Were looking for a Quality Engineer for our client Active Protective Technologies!

About Active Protective

Active Protective Technologies is a medical device startup committed to revolutionizing fall injury prevention and improving the lives of older adults. Our flagship product the Tango Belt integrates cuttingedge technology into a wearable device to mitigate fallinduced major hip injuries a leading cause of disability and fatal injury in older adults. The Tango Belt was designated a Breakthrough Device by the FDA to recognize its potential to significantly improve the standard of care for this debilitating condition. For more info on our mission and product please visit .

Job Overview

Active Protective seeks a Quality Engineer with both industrystandard technical skills and an attitude to contribute in a collaborative positive work environment to help assure product quality and improve our Quality System. In this role the Quality Engineer will perform a broad array of tasks to support our developing company but will be empowered to implement improvements as needed. We seek someone who can work autonomously willing to jump to complete a task and also provide support to peers.

Responsibilities

• Product Quality Assurance : Oversee quality assurance activities including the development of quality plans inspection and testing procedures and quality control measures. Develop tools and fixtures as necessary. Validate Processes and Software as necessary. Ensure that products meet defined quality criteria. Perform and manage nonconformance investigations as necessary.
• Quality Management Systems : Assist in maintaining quality management systems (QMS) in compliance with relevant regulatory requirements (e.g. ISO 13485 FDA 21 CFR Part 820). Ensure that processes are effectively documented executed and audited.
• Continuous Improvement : Lead continuous improvement initiatives to enhance product quality reduce defects and increase efficiency. Analyze quality metrics and trends to identify areas for improvement and implement corrective and preventive actions. Perform and manage CAPA investigations under direction.
• Supplier Quality Management : Manage and assess supplier quality including overseeing supplier role in design and change projects conducting audits evaluating performance and ensuring that supplier processes and products meet quality standards. Perform and manage SCAR under direction.
• Training and Development : Develop and deliver quality training programs for employees to ensure understanding and adherence to quality standards and procedures. Promote a qualityfocused culture across the organization.
• Documentation and Reporting : Maintain accurate and comprehensive quality documentation including records of inspections audits and corrective actions. Prepare and present regular quality reports to senior management.
• Customer Complaints : Investigate and resolve customer complaints related to product quality. Implement corrective actions and preventive measures to address root causes and prevent recurrence.
• Manufacturing : Support inhouse manufacturing as needed to ensure it meets GMP and consistently produces quality products.
• Design & Development : Support new product development and changes to product by offering designforquality input and ensuring design team follows established processes.
• Metrology : Maintain proper calibration on all quality inspection tools. Assist in maintaining calibration on manufacturing tools as requested.
• Tasks : Perform other tasks and duties assigned in order to meet company objectives.

Requirements

Physical Requirements :

Benefits

TOCGRP is proud to provide equalopportunity employment to all employees and applicants without regard to race creed color religion national origin citizenship ancestry age veteran status disability pregnancy marital status genetic information or any other categories protected by federal state or local law.

Education : Bachelor s degree in Engineering or a related field. A Master s degree or professional certification (e.g., CQE, CQA) is preferred. Experience : Minimum of 3-7 years of experience as a Quality Engineer within the medical device industry. Demonstrated experience with quality management systems, manufacturing, electronic products. Personal Skills : Strong communication skills, both written and verbal. Strong ability to work collaboratively with team-members, and to work under business direction. Technical Skills : Strong knowledge of quality management principles (ISO 13485). Proficiency with engineering tools and systems a plus (e.g. solidworks, 3D printing). Ability to engineer and / or machine fixtures a plus Proficiency with software and software systems a plus (e.g. python). Proficiency with electronics a plus (e.g. IEC 60601-1, IEC) Knowledge : In-depth understanding of medical device manufacturing processes, quality assurance practices, and industry standards. Physical Requirements : Possible business travel Must be fully vaccinated for COVID-19 (i.e., at least 2 weeks after last dose) and, if hired, present proof of vaccination by start date.

Education

Bachelor s degree in Engineering or a related field. A Master s degree or professional certification (e.g., CQE, CQA) is preferred.