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Quality Engineer I Additive Manufacturing
1 month ago
Come Create at Ricoh
If you are seeking a team driven by passion and purpose, come create with us at Ricoh. We are a team of information seekers and customer-obsessed collaborators who aspire to deliver the services, solutions, and technologies that empower business success. We are looking for talented, inspired individuals to join us to help drive high-performance team and our commitment to excellence.
Ricoh is an integrated solutions provider and partner that connects people and technology, creates outstanding customer experiences, and delivers innovation for businesses worldwide. We empower digital workplaces by enabling individuals to work smarter from any location and harness the power of information--how it is collected, stored, managed, and shared--to unlock the potential in every organization. We deliver services and technologies that inspire our customers' success and guide them toward a better and more sustainable future. If you are seeking a purpose-driven and passionate team, come create with us, and help drive our high-performance culture of excellence into tomorrow.
Invest in yourself
At Ricoh, you can:
- Choose from a broad selection of medical, dental, life, and disability insurance options.
- Contribute to your financial security with Retirement Savings Plan (401K), Health Savings Account (HSA), and Flexible Spending Account (FSA) investments.
- Augment your education with team member tuition assistance programs.
- Enjoy paid vacation time and paid holidays annually.
- Tap into many other benefits to enhance your health, wellness, and ongoing personal and professional development.
The Quality Engineer I plays a key role in the Ricoh 3D for Healthcare team's goal of onboarding customers through the intake of projects including both partner production and 3D printed medical devices. The position provides quality engineering support for all aspects of new process and product development for Ricoh 3D for Healthcare and their customers. The position will handle projects and tasks from inception through design/production transfer and play an active role to ensure products meet quality standards consistent with customer requirements, internal procedures, and acceptance criteria, while meeting all design control and other regulatory requirements.
JOB DUTIES AND RESPONSIBILITIES
Responsibilities include:
- Work with customers, engineering, and production teams as a participating design team member for process and product development projects.
- Responsible for the development and creation of inspection methods, inspection prints, gaging, or other inspection documents and detailed testing requirements to ensure product compliance.
- Create and update quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.).
- Support the creation of production documents such as DMR (Device Master Record) and quality records such as DHR (Device History Record or batch records) for new products and processes.
- Participate in the review and approval of Engineering Change Orders.
- Participate in the development and execution of design verification & validation and process validations.
- Support the design/manufacture transfer process to ensure compliance with the current design controls requirements and procedures.
- Ensure the efficient and timely transfer of process and quality systems knowledge to production personnel.
- Coordinate the training of production personnel on new quality procedures and inspection techniques.
- Participate in Risk Management throughout the medical device life cycle, including development, production, and post release.
- Review product and documentation non-conformances and recommend inspection, product and/or quality system modifications.
- Support various QMS processes including but not limited to NCs, CAPAs, deviations, and complaint root-cause investigations.
- Support the quality team in the selection, development, and qualification of new suppliers.
- Drive a customer centric quality culture and maintain compliance to applicable standards, regulations and internal QMS requirements.
- Performs other duties as assigned.
QUALIFICATIONS (Education, Experience, and Certifications)
- Bachelor's degree in engineering, preferably in biomedical, mechanical, or a related field; or equivalent combination of education and experience.
- 1-3 years of progressive engineering experience (manufacturing, development or quality engineering), preferably in the medical device industry.
- Strong working knowledge of ISO 13485 and ISO 14971, FDA Quality System Regulation 21 CFR Part 820 or CGMP.
- Strong working knowledge of inspection test plans, operating principles of metrology equipment, and ability to interpret and analyze drawings, specifications, and test results.
- Strong understanding of quality tools and methodologies, including FMEA, CAPA, and statistical analysis.
- Experience with product and process validation, design control, and risk management.
- Knowledge and experience with additive manufacturing a plus.
- Previous experience with industry standard workflow and automation systems, including electronic quality management system (QMS) software, is strongly
- Experience with standard business software
Ricoh is an EEO/Affirmative Action Employer -- Minorities/Women/Protected Veterans/Disabled.
