The Diabetes Care business unit has a long history within BD and is unique in that it focuses on one important disease state which is a threat to world health. The growth strategy includes strengthening our core diabetes drug delivery devices as well as enabling expansion of our diabetes care portfolio. Within the Diabetes Care business, you will have the opportunity to develop exciting new products and provide key contributions to BD's future growth.
The Staff Quality Engineer will work as a member of a cross-functional project team engaged in ongoing Product Life Cycle technical and engineering support. The individual will serve as a quality representative on project core teams and will work closely with R&D, Manufacturing, and Quality Systems engineers. This individual will be responsible for ensuring that the engineering projects are executed and released meeting customer expectations, regulatory requirements, appropriate voluntary standards, and BD policies and procedures.
The position requires a self-motivated, self-directed individual able to handle multiple 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 ofQuality Engineeringresponsibilities.
- Serve as a multi-functional team member establishing quality requirements and providing guidance for Product Life Cycle technical and engineering projects. Guides the successful completion of major programs and may function in a project leadership role
- Lead Risk Management evaluation of current products and process changes (in accordance with ISO14971)
- Develop and implement quality improvement programs
- Review validation protocols for effectiveness and compliance to Corporate Guidelines
- Assess current operations for quality and compliance
- Develop methods to measure, validate and assure quality standards are achieved for applicable product lines
- Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results
- Maintain documentation for compliance and effectiveness
- BS degree in Life Sciences or Engineering
- Minimum of 8 years of Medical Device industry experience.
- Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measureable / confirmed results
- Understanding of continuous improvement methodologies including Lean, Six Sigma, and validation. Lean Six Sigma certification preferred.
- Proficient knowledge of Medical Device or pharmaceutical regulatory standards such as cGMP, 21CFR820, ISO 13485:2003 and/or others relevant to Medical Devices.
- Excellent skills in analytical thinking and problem solving.
- Excellent written and oral communication skills.
- Proficiency in Microsoft Office suite and statistical programs (i.e. MiniTab, SAS).
- Knowledge of statistical methods.
- Experience with metrology/test methods and MSA (Measurement System Analysis / Gauge R&R) skills with the ability to analyze and improve measurement systems.
- Professional certification, e.g. American Society of Quality Certification in Quality Engineering or Reliabilitypreferred.
- Ability to travel domestically and limited international travel (25%)
Job ID R-319608