NPD Quality Engineer II

Job Summary

The Design Quality Engineer (DQE) II will plan, coordinate, and manage the quality assurance (QA) activities associated with one or multiple New Product Development (NPD) and/or Sustaining Design Changes projects to ensure compliance to internal and external requirements during the development and commercialization of new products. This individual will provide overall Quality Assurance (QA) leadership and partner with the NPD organization in efficient, effective, and rapid development and commercialization of new products. This individual will manage the effective oversight of Design Quality activities, as well as participate as an active QA representative on project teams. The DQE II manages the daily operation of the Design quality aspects of one or multiple projects by ensuring timely completion of Design Quality Assurance deliverables that meet the company standards for quality. This individual provides NPD teams with clear, consistent, and timely feedback as it relates to compliance exposure and will provide innovative solutions to effectively resolve investigations and to meet the needs of customers, regulatory bodies, and Terumo business requirements. 

As part of a project team, the DQE II will be responsible for developing sound Design History File deliverables, including, but not limited to, Quality Plans, Manufacturing Quality Plan, Design Verification protocols and reports, and conducting Design History File reviews at the end of each design control phase. In addition, the Principal, NPD QE will actively participate in design characterization, risk management activities, and design and process validation.  

The salary range for this position is $75,120 - $104,500 based on experience plus an annual 8% target bonus. 
 

Job Details/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.

Job Responsibilities (continued)

• 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. 

Internal contacts:   All departments, including manufacturing, engineering, marketing/sales.
External contacts: Customers and vendor contacts as required. 
 

Knowledge, Skills and Abilities (KSA)

• 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.
• Basic experience using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is desired.

Qualifications/ Background Experiences

• 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)