Job Description Summary

The Quality Engineer II is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate standards, and BD policies and procedures. This position will work as a member of a TTM cross-functional project team engaged in ongoing Product Life Cycle technical support. Will serve as a quality representative on project core teams and will work closely with R&D, Operations, Regulatory Affairs, Marketing and Distribution. This position requires a self-directed individual able to prioritize different projects and tasks utilizing a high level of written and oral communication skills. In addition, the incumbent may be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of Sustaining Engineering and/or New Product Development projects, and assume personal responsibility for the successful completion of all tasks within the realm of Quality Engineering responsibilities.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Summary:

The Quality Engineer II is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate standards, and BD policies and procedures. This position will work as a member of a TTM cross-functional project team engaged in ongoing Product Life Cycle technical support. Will serve as a quality representative on project core teams and will work closely with R&D, Operations, Regulatory Affairs, Marketing and Distribution. This position requires a self-directed individual able to prioritize different projects and tasks utilizing a high level of written and oral communication skills. In addition, the incumbent may be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of Sustaining Engineering and/or New Product Development projects, and assume personal responsibility for the successful completion of all tasks within the realm of Quality Engineering responsibilities.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Participates on Project Team as Quality Representative.  Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.

• Lead Quality Initiatives for Target Temperature Management products that include the entire product life cycle (Development, Commercialization and Post Market Surveillance).

• Creates, reviews, and approves Risk Management File documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s.

• Leadership in failure investigations, corrective and preventive actions plan and continuous improvement projects using methodologies as Six Sigma/Lean Six Sigma.

• Creates, reviews, and approves Design Specifications, Design Verification Protocols and reports, Process and Product Validations, Software Validation documents and Test Method Validations

• Creates, reviews and Improves Quality System Documents (CAPA, Audits, Risk Management, Design controls).

• Creates and reviews Product Documents.

• Participates in Internal, External and Supplier Quality Audits.

• Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.

• Interfaces with manufacturing facility or other Division Facilities.

• Travels as required by the above duties and responsibilities.

Education and Experience:

• B.S. in Engineering, Engineering Technology, Science a minimum. 

• Minimum 3 years of experience with FDA regulated industry, preferably on product development programs

• American Society of Quality (ASQ) certification (CQE, CRE,) preferred

• Lean Six Sigma green belt preferred

Knowledge and Skills:

• Knowledge of Medical