Quality Engineer II - Design & Reliability Assurance

About the role

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.

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.
• Career Development: 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 & 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

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

Additional Information

Salary Range: $71,300.00 - $97,750.00 USD

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.

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, and 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.