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Quality Engineer

Company: RCM Technologies
Location: Raynham
Posted on: May 9, 2022

Job Description:

Reference # : 22-00372 Title : Quality Engineer Location : Raynham, MA Position Type : Full Time/Contract Experience Level : Start Date / End Date : 05/16/2022 / 05/31/2023 Description Job Title: Quality EngineerJob Function: Support all processes related to base business operationsJob Type: Long term Contract (1+ years)Location: Onsite/Remote hybrid Southwest of BostonAbout RCM:RCM Life Sciences & IT is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.Scope of JobThe Quality Engineer supports all processes related to base business operations (day to day manufacturing of orthopedic implants) such as investigating process and product failures/challenges, identifying and implementing process improvement opportunities, partnering multi-functionally to strategize on continuous improvement, capacity expansion, corrective action development and implementation, sustaining projects, and detailing and/or reviewing required quality system documentation related to the above. In order to do so optimally they apply comprehensive and diverse knowledge of engineering and quality engineering principles and practices such as problem solving, root cause analysis and investigation, risk management, documentation, and communication skills.Primary Responsibilities Investigates process and product failures/challenges, documents investigations and implements corrections/corrective actions to mitigate the root cause and improve detection and control. Finds opportunities for process improvement and implementing improvements/corrective and preventative actions related to manufacturing processes by leading and participating on multi-functional teams concentrating on the aforementioned. Partners multi-functionally to ensure the accurate application and documentation of risk management (implementation and maintaining). Provide Quality Engineering support to multi-functional partners such as those in operations, engineering (process & manufacturing), supplier quality, and planning/procurement. Champions multi-functional communication and team work and promotes proactive quality in actions and behaviors. Serves as site support for all internal and external regulatory and compliance audits. Delivers and/or provides timely reviews/approval of quality records (NR, CAPA IP/AP/EM, Audit AP/EM, customer complaints), and risk documentation. Ensure compliance with all FDA, ISO, quality, safety and environmental regulations. Strategizes validation and verification approaches for projects and provides project planning/management support, as required. Knowledge & Experience Required: A minimum of 2 years of related experience Experience working in an FDA regulatory environment in manufacturing/operations The ability to perform "hands on " troubleshooting and problem solving The ability to think on the feet and providing good judgment Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) Strong communication and interpersonal skills Must have the ability to function in a team-based manufacturing environment The ability to collaborate with all levels of management in a multi-functional team environment Preferred: Good technical understanding of manufacturing equipment and processes Knowledge of product/process risk management (pFMEA) Knowledge of statistical data analysis tools (e.g. Minitab) Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc Understanding of the NPI (New Product Introduction) process and Process Validation expertise A thorough understanding of GMP/ISO regulations and validation regulations Demonstrated project management and project leadership abilities. ETQ (Documentation Storage) for CAPA's Experience with Adaptive for Doc Control Experience with design life cycle Design verification testing Design review experience Process capability experience Understanding of process scale up DFMEA experience, this goes hand and hand with Design review. DFMEA is design failure mode analysis Education A minimum of a bachelor's degree in engineering, Science, or related technical fieldEqual Opportunity Statement If you are interested, please forward your resume in MS Word format ASAP. to Contact: Pradeep at (908) 405-7974 RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.DisclaimerThis job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Keywords: RCM Technologies, Brockton , Quality Engineer, Engineering , Raynham, Massachusetts

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