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| Job Category : | Engineer |
| Company Name: | Resonetics, LLC |
| Position Name: | Quality Engineer |
| Location : | 115 Flanders Road, Westborough, MA 01581 |
| Job Description : | The Quality Engineer provides customer- and factory-facing quality support for contract manufacturing and development of medical device components and finished devices.The position includes:Managing the interface between Resonetics and customers’ supplier quality organization, assisting with transition and sustaining of laser micromanufacturing processes, and support for supplier quality management.For Design and Development Services (DDS): Serve as a key member of product development teams to perform activities related to design, development, process development and manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities.The Quality Engineer position uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, ISO 13485 and/or 21CFR820 compliance.ResponsibilitiesLiaising with customer quality personnel to resolve issues and Customer ComplaintsMonitoring and disseminating customer quality report cardsGenerating process deviations, Customer Change Notices, validation protocols & reports.Assisting with troubleshooting of production processes Assisting with the PDP processLeading development of metrology equipmentDeveloping and maintaining quality/control plansEnsuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development processes.Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMECAs.Conducting Gage R&R studiesResolving Corrective and Preventive ActionsDeveloping Quality Procedures and conducting training to all personnel as appropriateApproving Nonconformance dispositionAnalyzing production and validation dataWorking on continual improvement and process assessment projects as assignedFor Design and Development Services (DDS):Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.As a lead Quality Engineer on development projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds.Support Equipment Calibration and Maintenance per the applicable procedures.Required Qualifications-Education-Experience-SkillsMinimum 2 years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experienceDemonstrated technical writing and communication skillsWorking knowledge of Statistical software and/or MinitabBachelor’s degree or equivalent experienceInteract with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.Everyone is required to wear a mask upon entering the facility.Job Type: Full-timeBenefits:401(k)401(k) matchingDental insuranceFlexible spending accountHealth insuranceLife insurancePaid time offReferral programTuition reimbursementVision insuranceSchedule:8 hour shiftDay shiftMonday to FridayEducation:Bachelor’s (Preferred)Experience:SQL: 1 year (Preferred)Selenium: 1 year (Preferred)Test automation: 1 year (Preferred)Work Location: One location |
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