Kaztronix
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http://www.kaztronix.com
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Key Responsibilities:
Qualifications
Education:
Experience and Skills:
Required:
Preferred:
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Process Engineer, Manufacturing
Raynham, MA US
Job Description
Key Responsibilities:
- Writing and execution of validation protocols and reports (i.E. IQ, OQ, PQ, etc.)
- Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation.
- 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 strategy, author validation documents, coordinate execution and document approvals.
- Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects.
- Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
Qualifications
Education:
- 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 communicate across multiple audiences, including operators, peers and management, in both written and oral manners
- Process validation experience.
- Experience in a Medical Device and/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 (e.G. Minitab).
- Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
- Willingness to support global projects, which may include travel.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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Explore exciting job opportunities in and around Raynham, Massachusetts, a vibrant town nestled in the heart of Bristol County. Known for its picturesque landscapes, friendly neighborhoods, and bustling local businesses, Raynham is a hidden gem for career growth. From the historic Raynham Hall to the captivating performances at the Raynham Playhouse, this area offers a unique blend of history and modernity. Don't miss out on delicious seafood at local favorites like the Stoneforge Publick House or catch a game at the nearby Gillette Stadium, home to the New England Patriots. Whether you're seeking a cozy suburban lifestyle or craving a lively urban adventure, Raynham has something for everyone. Start your professional journey here and discover all the magic this town has to offer!