RQM+ Consulting Services - Manufacturing Quality Engineer- Remote

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Posted 13 days ago United States Salary undisclosed
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Job Description

RQM+ is the largest medical device and diagnostics focused full-service regulatory and quality consulting firm in the world. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.Manufacturing Quality EngineerOur Regulatory and Quality team members are REMOTE BASED, and travel occasionally to the client site.ResponsibilitiesParticipate in activities concerning the development, implementation, and maintenance of quality standards.Provide guidance and direction in First Article Inspection, pFMEA and Risk Analysis, Capability Studies, and customer driven requirements for device programs, GRConduct Supplier quality audits and lead investigations into Supplier Corrective Actions.Inspection of fixture design.Support manufacturing Site transfer.Develops Inspection Instructions/Techniques.Provide Statistical analysis support where needed.Utilizes CAPA and NCR systems to facilitate improvements.Identifies, quantifies, and monitors product and process quality and opportunities for improvement.Conducts or leads Process validation activities such as IQ OQ PQ, test method validations and gage R Develop validation protocols, with customer input, monitor execution, and develop completion reports for approval.Minimum Requirements: BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.3-7 years of experience in a regulated Medical Device environment in an engineering function dealing with processes and equipment in a cGMP/FDA/ISO manufacturing environment.• >Specialized Knowledge/Skills: A proven self-starter with the ability to identify areas of improvement and/or need and act accordingly to produce objective results.Excellent communication, organizational, and time management skills; ability to pay close attention to detail.Ability to work as part of a team and drive completion of action items.Flexibility to change direction frequently and with little notice.Ability to manage multiple priorities and tasks and projects.Strong problem-solving and analytical skills.Being an industry leader in regulatory and quality consulting is just the beginning for RQM+. We consider our Associates our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.