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Quality Assurance Engineer II
2 months ago
The Quality Assurance Engineer II plays a crucial role in guaranteeing that TTM products are developed and launched in alignment with customer expectations, regulatory standards, and BD's internal policies.
This role involves collaboration within a cross-functional project team at TTM, providing ongoing technical support throughout the Product Life Cycle.
The individual will act as a quality representative on core project teams, closely collaborating with Research & Development, Operations, Regulatory Affairs, Marketing, and Distribution.
This position demands a self-motivated professional capable of managing multiple projects and tasks while demonstrating exceptional written and verbal communication skills.
Additionally, the incumbent may be tasked with initiating quality improvement projects, gaining comprehensive knowledge of Sustaining Engineering and/or New Product Development projects, and taking personal accountability for the successful execution of all Quality Engineering responsibilities.
Key Responsibilities:
- Participate as the Quality Representative on Project Teams, ensuring adherence to Design Control principles for Product and Process Changes as well as New Product Development.
- Lead quality initiatives for Target Temperature Management products throughout the entire product life cycle, including Development, Commercialization, and Post Market Surveillance.
- Develop, review, and approve Risk Management File documents, including Risk Management Reports, Hazard Analyses, Risk Benefit Analyses, and FMEAs.
- Create Design Specifications, Design Verification Protocols, and reports, along with Process and Product Validations, Software Validation documents, and Test Method Validations.
- Provide leadership in failure investigations, corrective and preventive action plans, and continuous improvement projects utilizing methodologies such as Six Sigma/Lean Six Sigma.
- Review and enhance Quality System Documents (CAPA, Audits, Risk Management, Design controls).
- Engage in Internal, External, and Supplier Quality Audits.
Qualifications:
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Knowledge of Medical Device standards and regulations, including ISO 13485, ISO 14971, FDA regulations QSR, IEC standards, IEC 62304 Medical device software life cycle, and IEC 62366 Usability.
Experience in Design controls for electromechanical devices and disposables, including Risk Management, Design Verification, and Design Validation.
Familiarity with manufacturing processes.
Ability to comprehend Medical Devices Quality Systems and implement systemic changes to enhance product quality and improve operational efficiency.
Understanding of applied statistical concepts for Quality and Reliability, including statistical sampling plans, statistical process control, and advanced statistical methodologies such as DOE.
Education and Experience:
B.S. in Engineering, Engineering Technology, or Science is required.
A minimum of 3 years of demonstrated experience in the FDA-regulated industry, preferably within product development programs.
Certification from the American Society of Quality (ASQ) (CQE, CQA, CQM, etc.) is preferred.
Why Work with Us?
At BD, we are dedicated to investing in our associates' well-being and development, offering competitive compensation and benefits programs.
We foster a culture that values your contributions and encourages you to bring your authentic self to work, ensuring a supportive environment for learning and growth.
Join us in our mission to advance the world of health and make a meaningful impact.
