Terumo Medical Corporation · 15 hours ago
NPD Quality Engineer II
Elkton, MD
Full-time
Onsite
Mid Level
$75K/yr - $104K/yr
3+ years expTerumo Medical Corporation is seeking a Design Quality Engineer II to lead quality assurance activities for New Product Development projects. The role involves ensuring compliance with internal and external quality standards, providing oversight on design quality activities, and collaborating with project teams to meet quality deliverables.
HardwareHealth CareHealth DiagnosticsIndustrial ManufacturingManufacturingMedicalMedical Device
Hiring Manager
Andre Thompson
Responsibilities
Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards
Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned project activities
Lead quality system development and implementation throughout product life cycle
Provide oversight for internal and external metrology, incoming inspection, acceptance criteria, disposition of non-conforming materials, and measurement system evaluations
Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs
Review and approve/reject technical transfer plans and reports from the design transfer perspective. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and evaluated
Lead teams and ensure completion of Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with limited guidance required
Leads cross functional team on how to documents changes, using a risk-based approach for determining requirements
Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other related products
Develop and validate test methods
Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with moderate complexity
Review and approve product and process qualification and validation and other change control related documentation
Active role in improving and drafting internal quality documentation such as quality plans, standard operating procedures, and inspection procedures
Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints
Performs analytical measurements and experiments to qualify or resolve product and process issues
Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions
Support field quality and analyze field returns to determine root cause
Provide training and support for quality system processes and quality engineering practices
Provide support as a Quality Assurance Team member to work with Engineering and Systems Teams to resolve issues related to Design Verification and Design Validation
Clear understanding of Process Validation Principles and ability to support Process Qualification efforts (IQ, OQ, PQ etc.) for all classes of medical devices
Qualification
Required
BS in engineering, biomedical, life sciences, or similar discipline from an accredited university or college
Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and/or manufacturing
Minimum of 3 years of experience in an engineering and/or scientific environment
Minimum of 2 years of experience in a regulated industry (medical device industry preferred)
Effective communication skills both verbal and written. Communicates effectively with internal teams and may present findings to small groups
Strong organizational skills as well as time management skills essential for project work
Self-motivating and able to balance multiple priorities and tight deadlines with limited supervision
Excellent computer skills
Strong writing, mathematics, and statistics skills
Demonstrated working knowledge of key medical device related standards including 21 CFR 820 (Quality Systems Medical Devices), Design Controls, ISO 13485, and ISO 14791
Preferred
Basic experience using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is desired
Company
Terumo Medical Corporation
Our Promise At Terumo, everything starts with our unwavering commitment to patients.
1001-5000 employees
H1B Sponsorship
Terumo Medical Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (5)
2023 (2)
2022 (2)
2021 (4)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Shahnawaz Khan
CTO & Head of IT
Michael J M.
Sr. VP, Medcal Affairs, Chief Medical Officer
Recent News
Orchestra BioMed Holdings, Inc.
2025-10-28
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