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Actalent Quality Engineer in Waltham, Massachusetts

Description:

• Minimum 4-year degree in Engineering or Bio-Medical Engineering. • 5+ years’ experience as a Quality Engineer in the medical device industry. • In lieu of degree additional work experience will be considered. • Technical skills including the ability to read technical specifications; utilize measurement tools & equipment. • QSR and ISO13485 experience required. • Must have experience in CAPA, NCMR, validation (IQ, OQ, PQ, etc.), DMR, DHR, risk management activities, statistics and design controls. • Interfaces with all departments in the organization in matters related to the quality system compliance and functional performance of product.

Skills:

quality system, quality system documentation, iso 13485, medical device, quality engineering, quality assurance, risk management, failure analysis, failure mode and effects analysis fmea software, fmea, pfmea, engineering, quality management, quality standards, mrb, material review board, mechanical engineering, audit, root cause analysis, supplier quality, capa, internal audit, non conforming, lean manufacturing, lean six sigma, lean manufacturing engineering, quality inspection, iq oq, robotics, biomedical, biomedical engineering, validation, eco, quality control, document control, iso 9001, iso standards, design history records

Top Skills Details:

quality system,quality system documentation,iso 13485,medical device,quality engineering,quality assurance,risk management,failure analysis,failure mode and effects analysis fmea software,fmea,pfmea,engineering,quality management,quality standards

Additional Skills & Qualifications:

Bachelor’s degree or equivalent with 1+ years of cGMP experience. Prior experience working in a Quality/Compliance role within the pharmaceutical or medical device industry. Experience writing and reviewing technical cGMP documents. Experience with an electronic Quality/Document Management System. Strong written and verbal communication. Experience operating in an environment with strict timelines. Change Control/Design Control: Support the process of change control approval from evaluation of an initial proposal through approval, implementation, closure and effectiveness review. Provide QA support of change controls to ensure that they meet the requirements of standards and procedures, and are clearly written and appropriately justified. Provide QA approval of those changes at various points in the change life cycle, utilizing a quality management system electronic workflow. Apply and interpret procedures governing the change control process to proposed changes, consulting with QA management as appropriate. Work with project teams to determine the change control approach for projects. Verify the completeness and correctness of supporting documentation for changes, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes. Assist in the management of the Design Control program, updates to Design History Files, and participate as a Quality representative in the design review process. Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system. Risk Management: Assist with driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management. Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations.

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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