Sr Quality Engineer, Design Assurance

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Design Quality Assurance Engineer (DQA) is responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation project(s) of varying scope and complexity in the Tissue Technology (TT) division, as well as risk management work for new and existing products. The DAQ Engineer will interact with design and development partners, participating on cross-functional project teams through all phases of the product development process, and assisting the technical team with planning, executing, documenting, and communicating testing activities.

The role works closely with Product Development, Project Management, Regulatory, Marketing, Manufacturing Facilities and Medical Affairs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

* Support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs. Support Design Reviews, Technical Reviews, and Gate Reviews.

* Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs.

* Author or review for approval other Risk Management Documentation: PSRA, Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA).

* Support Internal partners in the development of products; including review and approval of development documentation such as product requirements, schematics, verification, and validation strategy/execution.

* Coordinate, review and approve development documentation created by external partners.

* Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer.

* Maintains knowledge of and applies statistical analysis to support data-driven decision making.

* Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.

* Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary.

* Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert.

* Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects.

* Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements.

* Identify and implement opportunities for continuous improvement in the quality system.

* Interact and coordinate activities with other departments, external vendors, and customers.

* Perform other Quality Systems related duties as required.

Education & Experience:

* Bachelor's degree in Science, Engineering (Biomedical, Mechanical or Electrical) or related discipline.

* 4+ years of experience in Quality Engineering, process engineering or R&D Engineering for medical device.

* Proficient in the application of risk management and design control standards and best practices to NPD and LSM.

* Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making.

* Demonstrated knowledge and understanding of applicable national and international regulations and standards.

* Demonstrates excellent organizational, verbal and written communication skills.

* Proficient with the MS Office Suite, and statistical software.

* Must be able to work independently with minimal supervision.

* Able to prioritize projects and manage time to meet organizational goals and objectives.

* Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA).

* Knowledge of Track Wise preferred.

* Knowledge of Agile product lifecycle management system preferred.

* Ability to utilize MS Office Suite

* Ability to work with Minitab for statistical analysis

Salary Pay Range:

$81,650.00 - $ USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans,…