Quality Engineer I Department: Shared ServicesLocation: Lowell, MASTART YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?reqid=3246750&source=3246750-CJB-0) About us:For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!Position Summary: This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Provide support to product development teams and sustaining manufacturing/operations teams. This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross-functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy. Interact with customers and suppliers in support of engineering projects. Key Responsibilities:
Perform Design Quality Engineering activities throughout the design, development, and production of medical devices to ensure compliance to company-s Design Control procedure and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485).
Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams.
Provide Quality Engineering support for engineering project development, or sustained manufacturing.
Provide Quality Project Management support as needed for product transfers from development through validation.
Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
Develop and maintain Validation Standard Operating Procedures.
Develop and maintain project Quality Plan for assigned projects.
Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
Support Corporate Quality Management System initiatives and continuous improvement activities.
Provide support for generation, tracking/trending & reporting of quality system metrics, as required.
Support site customer-requested auditing activities (Customer and Regulatory Agencies).
CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
Audit support for third party audits, customer audits and internal audits.
Support the implementation of continuous improvement initiatives for production processes.
Develop and maintain production quality control plans.
Initiate and maintain SPC (Statistical Process Control) for production processes.
Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
Must Have:
Bachelor-s degree in engineering discipline with 0 years of experience; or a combination of education and relevant work experience/
Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
Must be able to read, write, and speak fluent English.
Must possess excellent verbal communication, organizational and management skills.
Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
Salary Range: $73,700 - $84,100Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec-s goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?reqid=3246750&source=3246750-CJB-0)
