All Visa Accepted: Urgent Hiring : Title: Validation Engineer-in medical device, Location: Raynham, MA(ONSITE)
Saloni Km
Greetings,
My name is Saloni from KK Technologies
LLC. I have a position with one of our premier clients. Please review the job description below. if you are interested in this position, please forward your update resume for immediate consideration.
Title: Validation Engineer-in medical device
Location: Raynham, MA(ONSITE)
Key Responsibilities:
Writing and execution of validation protocols and reports (Le IQ, OQ, PQ, etc.)
Developing and implementing manufacturing processes, preparatiori of specifications and operator instructions, process studies, production readiness, investigations, root cause
Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system.
Working with OEM equipment manufacturers and distributors to develop user requirements.
Work on new asset commissioning
Working with multi functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strate to align on validation strategy, author validation documents, coordinate execution and discomment approvals
Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
Ensuring compliance with US. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects
Qualifications
Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
Experience and Skills:
Required:
2-4 years of experience in manufacturing and/or process engineering
Strong technical writing skills, with appropriate awareness of intended audience.
Ability to effectively communicats across multiple audiences, including operators, peers and management, in both written and onal manners
Process validation experience
Experience in a Medical Device arid/or regulated manufacturing work environment
Persuasive communication and interpersonal skills
Digital literacy, including use of Microsoft Office tools.
Preferred:
Experience working in a regulated industry, such as Medical Device.
Experience with machining processes, metal finishing processes, laser processing or production automation. Hands-on experience with machining processes, casting, metal finishing processes, laser processing or production automation.
Knowledge of statistical data analysis and associated tools (eg. Minitab). Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Willingness to support global projects, which may include travel."
Regards,
Saloni
KK Technologies LLC
2377 Gold Meadow Way,
Suite 100, Gold River, CA