BD (Tissuemed Ltd) · 2 months ago
Quality Engineer II / Sr Quality Engineer
Hunt Valley, MD
Full-time
Onsite
Mid, Senior Level
$73K/yr - $121K/yr
2+ years expBD is one of the largest global medical technology companies in the world. The Quality Engineer II/Sr role is responsible for applying Quality Systems, developing Standard Operating Procedures, and ensuring compliance with regulatory requirements while providing guidance on quality processes and continuous improvement.
Health CareHospitalMedicalMedical Device
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
Required
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
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
Bachelor's degree and 5 Years' experience within the quality function or Master's Degree with minimum of 3 years' experience in quality
Bachelor's degree
Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs
Other fields can be considered with the appropriate experience to support the role
Advanced degree can make up for experience requirement
2+ years experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations
Preferred
Clinical Diagnostic experience a plus
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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