Quality Engineer II - Design & Reliability Assurance

Integra LifeSciences; Princeton (NJ); On-site; USD 71,300 - 97,750; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) savings plan

Life and disability insurance

Job summary

Integra LifeSciences in Princeton, NJ is seeking a Design Quality Assurance Engineer to support New Product Development and ensure compliance with regulations. The role will involve risk management, interacting with cross-functional teams, and maintaining quality system compliance.

Ideal candidates will have a Bachelor’s degree in a relevant field, over 4 years of experience in Quality Engineering, strong statistical and risk management skills, and the ability to work independently.

Qualifications

• 4+ years of experience in Quality Engineering or R&D Engineering for medical devices.
• Proficient in risk management standards and design control.
• Experience with external regulatory agency audits.

Responsibilities

• Support design and development of new products.
• Lead execution of Risk Management and Usability Engineering processes.
• Coordinate development documentation with internal and external partners.

Skills

Risk management

Statistical analysis

Organizational skills

Communication (verbal and written)

Independent work

Education

Bachelor’s degree in Science, Engineering or related discipline

Tools

MS Office Suite

Minitab

Job description

The Design Quality Assurance Engineer (DQA) is responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation projects of varying scope and complexity in the Tissue Technology division, as well as risk management work for new and existing products. The DQA 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.
• Maintain knowledge of and apply 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 and 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.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

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 TrackWise 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

$71,300.00 – $97,750.00 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.

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences.

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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans.

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 [e-mail].