Quality Test Engineer

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Quality Test Engineer plans, performs and leads lab validation activities that support the feasibility of new/improved lab concepts or technologies (equipment, software, test methods, etc.) required to support the development of new products and/or the robustness of commercial products. Other responsibilities may include, but are not limited to, supporting product release activities, including identification of product defects and potential issues, and the management of complaints for commercially released product from investigations through data analysis and trending.

This position is also responsible for proactively managing complex issues with a high level of autonomy and is accountable for the success of all activities and deliverables while ensuring related operations comply with BD policies and procedures, as well as applicable regulations and standards.

Responsibilities:

• Serves as a technical expert on laboratory instrumentation, equipment and processes.
  • Plans and performs equipment qualifications, test method validations, fixture development, and computerized software validations, as needed.
  • Performs remediation activities and implements improvements, as needed.
• Independently plans and performs experiments that support new or commercial products or technology testing. Develops new methodologies or conducts routine procedures, as needed.
• Leads or contributes to nonconformance investigations, root cause analysis, corrective / preventive actions, etc.
• Performs applicable release testing or product testing, maintains documentation, and reviews inspection results.
• Leads or facilitates applicable complaint management process of commercial product, as needed, including sample management, activities performed by support team(s) or supplier(s), reporting and trending
• Supports equipment calibration / preventive maintenance / repair activities and investigations, as needed

• Independently identifies and creates/improves procedures to address gaps in laboratory processes.
• Identifies and supports qualifications of new lab suppliers, when needed. Supports Supplier Quality team with maintenance activities for existing suppliers.
• Maintains laboratory safety and organization as well as operational and functional conditions.
• Maintains inventory of laboratory supplies, test samples, and drug/placebo.
• Ability to work effectively in cross-functional project teams, when needed. Assists Design Quality Engineers, Complaints team, and/or release teams.

• Supports audits, as needed

• Maintains good laboratory practices (GLP) consistent with BD and regulatory guidelines.

• Maintains good documentation practices (GDP) when generating test data and records in accordance to ISO, cGMP and other applicable regulations and standards.

Education and Experience

• BS degree in in Engineering, Science, or other related discipline
• Minimum 5 years experience is required or equivalent education.
• Medical device, pharmaceutical, or diagnostic industry experience preferred.

Knowledge and Skills

• Experience with software validation highly desirable
• Working knowledge of the operation of mechanical measurement equipment (e.g. Instron) desirable
• Proficient communication (written and oral), organizational and interpersonal skills.
• Ability to perform multiple tasks simultaneously and prioritize…