The Quality Engineer will plan, coordinate, and manage the quality assurance (QA) activities associated with one or multiple New Product Development (NPD) projects to ensure compliance to internal and external requirements during the development and commercialization of new products. This individual will provide 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 NPD QA activities, as well as participate as an active QA representative on project teams. The NPD QE manages the daily operation of the NPD quality aspects of one or multiple projects by ensuring timely completion of NPD 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 KORU business requirements. As part of a project team, the Senior NPD QE will be responsible for developing sound Design History File deliverables, including, but not limited to, Quality Plans, Supplier Qualification Strategies/Quality Agreements, Manufacturing Quality Plan, Design Verification protocols and reports, and conducting Design History File Verifications 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.
What you will do:
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 tested.
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 no guidance required.
Leads cross functional team on how to documents changes, using a risk-based approach for determining requirements.
Lead validation planning sessions for projects of all levels of complexity with no guidance required.
Addresses defect prevention through review of quality history, supplier base controls, scrap analysis, process control techniques and training.
Acts as the Technical Specialist to Purchasing in supplier-related quality issues.
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 similar products
Participate in supplier selection process and component specification reviews to ensure that purchased items meet specifications
Develop and validate quality 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.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Review and approve product and process qualification and validation and other change control related documentation.
Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures.
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.
Monitor field quality and analyze field returns to determine root cause.
What we are looking for:
- Engineering Degree
- 4 or more years of NPD Quality Experience including risk mgt, design controls, DHF, tech files US and OUS.
- Experience with Validation
- Experience interfacing with external auditors
- CAPA experience is preferred
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore, employees assigned may be required to perform additional job tasks required by the manager.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
KORU Medical Systems provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, marital status, pregnancy, parental status, national origin, ethnic background, age, disability, political opinion, social status, veteran status, union membership or genetics.
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