Principal Quality Engineer
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
Principal Quality Engineer I, is a hands-on key position with responsibility for the following areas: in-house and contracted Quality agreements review and implementation, project management, Quality engineering support including, manufacturing/facilities/equipment planning/engineering, document control/training, audits, quality systems, and safety programs in accordance with the company’s Quality System and customer requirement
1. In-House and Contract Quality: Establish and manage in-house and/or contract Quality activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements. Prepare and deliver quality status reports. Direct and coordinate contract product or related testing to ensure quality requirements are met. Development of required Quality inspection and test processes and determining appropriate sampling plans. Work with Quality/manufacturing personnel and staff to define and resolve quality and yield issues by evaluating and enhancing current and scheduled processes. Review completes and/or approves of investigations involving non-conforming materials, subassemblies and/or finished goods including risk analyses with impact to product and to the business and regulations. Review and approve DHRs/LHRs and product release forms with no GDP errors.
2. Project Engineering: As part of a project team, or on an individual basis contribute to the development of detailed specification, construction of prototypes for new products or current product enhancements. May be required to manage individual projects. Develop new quality tests or inspections methods for new products including test methods validations. Set up, train, and run product testing and protocols in accordance with project plans, timelines, and budget. Research and recommend suppliers and material choices for product. Ensure that product documentation is in accordance with Quality System requirements.
3. Project Management: Provide input and may coordinate multi-functional project team activities from early project conceptualization through clinical testing when required. Create, maintain, and manage overall project schedule, and ensure that critical timelines and/or budgets are established and met. Conduct regular project team meetings to ensure communication between multi-functional team members. Develop positive proactive working relationships with team members and other internal/external customer.
4. Quality Engineering: Develop Quality engineering and inspection/test process specifications for products scheduled for release to market and coordinate all process validation activities. Determine inspection tools/equipment needs for the timely and cost-effective quality testing of products. Work with OPS and RD staff to ensure smooth transition and manufacturability and testing of products in conformance with regulatory and Company requirements.
5. Product Enhancements: Support activities to design prototypes and product modifications in response to pre-clinical trials and customer feedback. Research, design and develop new products and current product enhancements in accordance with Quality System requirements.
6. Facilities/Equipment Planning/Engineering: Manage Quality equipment and qualification to ensure that equipment is cost effective and meets Quality specifications. Work with Equipment coordinator for all calibration and preventive maintenance activities in accordance with the Company's Quality System requirement
7. Supervision: May be required to supervise, lead or train QA Engineers, inspectors, and Technicians
8. Regulatory Compliance: Provide quality engineering support in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies
9. Responsibilities to the Quality System: Be an SME for activities within the Quality System and support Quality Policy. Annually review changes in Quality System standard operating procedures (SOPs) and applicable regulatory standards. Self-train and provide training for position activities. Ensure subordinate staff are trained in applicable procedures prior to performing Quality related activities. Inform responsible personnel of concerns involving product quality issues.
10. Intellectual Property: Ensures technical activities are properly documented in lab notebook and witnessed. Participates in and contributes to technical discussion sessions to generate new intellectual property
11. Safety: Perform all activities and documentation related to employee health and safety and ensure compliance with all legal and regulatory requirements. May be responsible to be a part of safety committee. Performs job functions in a safe and effective manner. Ensures that employees under position supervision are adhering to the safety procedures of the company.
12. Other Duties: As assigned
Knowledge, Skills and Abilities (KSAs)
Demonstrated skill in technical writing. Ability to independently author all levels of documents under general supervision. Ability to review and approve all levels of documents under general supervision.
Strong verbal and written communication skills, ability to present to a broad audience (company personnel, suppliers, customers). Effective communication across all levels of the organization.
Thorough understanding of key regulations/standards for medical product manufacturing and development: 21 CFR 820 (Quality System Regulation), 21 CFR 803 and 804 (MDR regulations), ISO 13485, ISO 14971, and MDD 93/42/EE.
Demonstrated personal initiative and ability to work independently while handling multiple tasks.
Demonstrated team leadership and development skills including training of functional personnel to applicable standards.
Demonstrated ability to manage complex projects including organization and reporting under general supervision.
Proficiency using general business software like Microsoft Office and Windows® applications; Word, Excel, PowerPoint, Project.
Demonstrated ability to manage and/or mentor lower level Engineers, Technicians, and co-ops. Ability to train lower level Engineers, Assemblers, and Technicians to applicable standards.
Skilled in the use of statistical analysis software such as Excel or Minitab.
Knowledge of data collection, analysis, and documentation techniques.
Knowledge of FDA Code of Federal Regulations (CFRs) and ISO regulations.
Certification as a Quality Engineer or Quality Auditor by the American Society for Quality (preferred).
Bachelor’s degree in sciences, Engineering or related discipline required or equivalent combination of education, training and experience.
14+ years previous experience in design, manufacturing or quality engineering.
5+ years’ experience in Medical Device or related industry.
Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
Experience in a start-up environment (preferred)• Experience with Design Control procedures, dFMEA, pFMEA, uFMEA, risk management and requirements.
Experience working with suppliers including contract manufacturers on product quality issues.
Experience evaluating suppliers including on-site auditing.
Experience in writing SOPs and other high-level quality documents.
Experience with process and test method validation including sterilization, packaging, and shelf life.
Experience with product testing for lot release, including review of lot history records.
Experience writing and completing protocols, including authoring of final reports.
Experience with catheter-based medical devices (preferred).
Previous project management experience (preferred).
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
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Posted 2 months ago
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