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BD · 2 months ago

Quality Engineer II / Sr Quality Engineer

USA MD - Hunt Valley

Full-time

Onsite

Mid, Senior Level

$73K/yr - $121K/yr

2+ years exp

BD is one of the largest global medical technology companies in the world, dedicated to advancing health through innovative solutions. The Quality Engineer II/Sr Quality Engineer will be responsible for applying and interpreting quality systems, developing standard operating procedures, and ensuring compliance with regulatory requirements, while also providing guidance on process control and continuous improvement initiatives.

Health CareMedical DeviceTechnical Support

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Required experience in independently writing and executing process validation protocols

Experience in a medical device or pharmaceutical manufacturing facility

Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485

Clinical Diagnostic experience a plus

Ability and skill to effectively manage multiple tasks and drive execution of change management plans

Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC

Provide on site validations of equipment, software and materials, for the Baltimore/Sparks reagent plants

Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies

Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments

Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans, trending and design control

Initiates and/or supports CAPAs and may lead the investigation/corrective action process

Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products

Responsible for initiating and coordinating SAP master data and documentation for product changes and new products

Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes

Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures to support operations day to day

Supports internal and external audits and assists in administering the audit program

Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements

Facilitates investigation of customer complaints. Implement revision to TI's based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints

Defines Change Control requirements for the plant related to manufacturing, facility and material changes. May provide full support to raw material changes assuring that all Quality Systems and requirements are met

Qualification

Process validationFDA 21 CFR 820ISO 13485Statistical toolsQuality SystemsCAPA managementContinuous improvementRisk analysisProject managementTeam collaboration

Required