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BD (Tissuemed Ltd) · 1 month ago

Quality Engineer II (Instrument Plant)

Sparks, MD

Contract

Onsite

Entry, Mid Level

$73K/yr - $121K/yr

2+ years exp

BD is one of the largest global medical technology companies in the world, and they are seeking a Quality Engineer II to ensure compliance with Quality Systems and support product lines and processes. The role involves maintaining regulatory requirements, developing Device History Files, and performing risk management and trend analysis.

Health CareHospitalMedicalMedical Device

Responsibilities

Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle

Develop Device History Files and maintain in a manner consistent with regulatory requirements

Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with project team/operations/suppliers

Supports the coordinated integration of new products into Manufacturing / Operations

Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies

Understanding and coaching others on Quality Systems and procedures

Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools

Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision

Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations

Computer skills in word processing, spreadsheets and a statistical package required. Must have excellent communication skills

Knowledge of manufacturing processes, use of statistical tools required, and knowledge of microbiological and chemical test methods are preferred

Experience using statistical methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred

Qualification

Quality SystemsStatistical toolsRisk managementMedical device regulationsSAP transaction experienceData analysisComplaint investigationTeam collaborationCommunication skillsProblem-solving

Required

Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields can be considered with the appropriate experience to support the role. An advanced degree can make up for experience requirement

2+ years' experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations

Experience in a medical device or pharmaceutical manufacturing facility

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

SAP transaction experience

Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity

Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003

Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision

Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations

Computer skills in word processing, spreadsheets and a statistical package required

Must have excellent communication skills

Experience using statistical methods is required