Senior Quality Engineer I - Design Reliability Assurance
Senior Quality Engineer I - 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 Senior Quality Engineer I Design & Reliability Assurance (DRA) 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 leads and supports the design and development of new and improved products. The (DRA) Sr. Engineer will interact with external design and development partners participating on crossfunctional 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 and Medical Affairs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
This role is a seasoned professional engineer with complete and indepth conceptual knowledge of quality engineering. They are knowledge of quality engineering best practices to internal processes and manages work with minimal guidance and direction.
The Senior Quality Engineer I works to achieve operational targets for specific programs and projects with significant impact on departmental results
Lead 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.
Lead and support the of all Risk Management and Usability Engineering process activities including design process and application FMEAs.
Author or 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 review and approve development documentation created by external partners.
Develop Reliability models for predicting product performance over time (where applicable).
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 datadriven 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.
Authoring & 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.
Works to build consensus within project teams as well as through management of processes and programs. Explains information with junior members of the team through informal training & work responsibilities
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 5 years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing or equivalent education and years of experience.
Onsite position in Boston MA with transition to a brandnew state of the art facility in Braintree MA in 2025.
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
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA) reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position the employee must repeatedly sit listen speak type and move throughout the facility. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed.
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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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation please email us at or call us at.
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Required Experience:
Senior IC
Employment Type
Full-Time
