Quality Engineer II - Design Reliability Assurance
Quality Engineer II - Design Reliability Assurance
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1 Vacancy
Job Description
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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Quality Design and Reliability Assurance (DRA) Engineer II 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 specifically the Boston/ Braintree site. The role contributes and
supports the design and development of new and improved products. The (DRA)
Engineer II will interact with external design and development partners participating on
crossfunctional project teams through all phases of the product development process andassisting the technical team with planning executing documenting and communicatingtesting activities. The role works with Product Development Project ManagementRegulatory Marketing and Medical Affairs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Understand and 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.
Understand and support the of all Risk Management and Usability Engineering process activities including design process and application FMEAs.
Review for approval other Risk Management Documentation: Risk Management Plan/Report Hazard Analysis BenefitRisk Analysis (BRA).
Support external partners in the development of products including review
and approval of development documentation such as product
requirements schematics verification and validation strategy/.
Coordinate and review development documentation created by external
partners.
Develop Reliability models for predicting product performance over time
(where applicable).
Support implementation of SPC programs with Manufacturing and Quality
Control as a part of Process Validation and Design Transfer.
Knowledgeable of and applies statistical analysis to support datadriven
decision making.
Work with project teams to develop DOEs and statistically sound tests for
appropriate support of results.
Supports developing 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.
Maintain 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.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge skill and/or ability
required for this position.
Education & Experience:
Bachelors degree in science Engineering (Biomedical or Mechanical) or related
discipline with 3 years of experience in Quality Assurance role for medical
device or pharmaceutical manufacturing or equivalent education and years of
experience. Or masters degree in science Engineering (Biomedical or
Mechanical) or related discipline with 02 years of experience or equivalent
education and years of experience.
Demonstrates excellent knowledge of statistical sampling and analysis
tools/methods to support datadriven decision making.
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 TrackWise preferred.
Knowledge of Agile product lifecycle management system preferred.
Demonstrated knowledge and understanding of applicable national and
international regulations and standards for Design Controls.
TOOLS AND EQUIPMENT USED
Ability to utilize MS Office Suite
Ability to work with Minitab for statistical analysis
Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.
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Employment Type
Full-Time
