BD (Tissuemed Ltd)
Quality Engineer II / Sr Quality Engineer
BD (Tissuemed Ltd), Cockeysville, Maryland, United States, 21030
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Quality Engineer II / Sr Quality Engineer
role at
BD (Tissuemed Ltd)
Overview
The Quality Engineer II/Sr title will be determined based on prior experience. The general requirements will be the same. The degree of independence and oversight will vary based on the associate being determined to be a QEII or Sr QE.
Job Description Summary
This position is responsible for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policies for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant. The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Responsibility for process validation across all media plants. Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. Will support both internal and external audits.
Responsibilities
Monitor and trend quality indicators for purchased materials as well as manufactured and distributed components/products.
Assess Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow.
Take responsibility for CAPAs and may lead the investigation/corrective action process.
Day to day QM Engineering responsibilities for product and related operational areas. Support departmental compliance with ISO and FDA requirements through training and initiatives.
Develop, document, administer and maintain Quality Systems for conformance, regulatory requirements and company policies.
Provide advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge, independently and in teams.
Use tools including FMEA, risk analysis, validation, project management, sampling plans, Six Sigma, control plans, trending and design control.
Support implementation of corrective actions and improvements by coordinating SAP data/documentation in current products; initiate and coordinate SAP master data and documentation for product changes and new products.
Drive continuous improvement across areas; participate in Continuous Improvement teams and verify effectiveness of changes.
Perform duties in compliance with BDDS Quality, Safety and Operating Procedures to support day-to-day operations.
Support internal and external audits and assist in administering the audit program.
Develop and maintain efficient methods for reporting to management the current status of product quality relative to Quality objectives and generate quality system improvements.
Facilitate investigation of customer complaints; implement revisions based on complaint analysis and initiate preventive/action plans in response to valid customer complaints.
Define Change Control requirements for the plant related to manufacturing, facility and material changes; provide support to raw material changes ensuring Quality Systems are met.
Qualifications
Sr QE : Bachelor’s degree and 5 years of experience within the quality function, or Master’s Degree with a minimum of 3 years in quality.
QEII : Bachelor’s degree; typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields considered with relevant experience. Advanced degree can substitute for experience. 2+ years of experience in Quality Assurance, Quality Control, or product/process non-conformance investigations.
Additional information
At BD, on-site collaboration is prioritized and roles may require a minimum in-office presence per week; remote or field-based arrangements will be indicated in the job posting. Employment may be contingent upon proof of full vaccination against COVID-19 where required by location. BD’s Workplace Accommodations Policy will be followed for applicable requests.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and growth every day.
To learn more about BD, visit our Careers site.
Salary Range Information
$73,300.00 - $121,000.00 USD Annual
Primary Work Location
USA MD - Hunt Valley
BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, familial status, sexual orientation, gender identity or expression, genetics, disability, military status, and other legally protected characteristics.
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Quality Engineer II / Sr Quality Engineer
role at
BD (Tissuemed Ltd)
Overview
The Quality Engineer II/Sr title will be determined based on prior experience. The general requirements will be the same. The degree of independence and oversight will vary based on the associate being determined to be a QEII or Sr QE.
Job Description Summary
This position is responsible for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policies for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant. The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Responsibility for process validation across all media plants. Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. Will support both internal and external audits.
Responsibilities
Monitor and trend quality indicators for purchased materials as well as manufactured and distributed components/products.
Assess Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow.
Take responsibility for CAPAs and may lead the investigation/corrective action process.
Day to day QM Engineering responsibilities for product and related operational areas. Support departmental compliance with ISO and FDA requirements through training and initiatives.
Develop, document, administer and maintain Quality Systems for conformance, regulatory requirements and company policies.
Provide advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge, independently and in teams.
Use tools including FMEA, risk analysis, validation, project management, sampling plans, Six Sigma, control plans, trending and design control.
Support implementation of corrective actions and improvements by coordinating SAP data/documentation in current products; initiate and coordinate SAP master data and documentation for product changes and new products.
Drive continuous improvement across areas; participate in Continuous Improvement teams and verify effectiveness of changes.
Perform duties in compliance with BDDS Quality, Safety and Operating Procedures to support day-to-day operations.
Support internal and external audits and assist in administering the audit program.
Develop and maintain efficient methods for reporting to management the current status of product quality relative to Quality objectives and generate quality system improvements.
Facilitate investigation of customer complaints; implement revisions based on complaint analysis and initiate preventive/action plans in response to valid customer complaints.
Define Change Control requirements for the plant related to manufacturing, facility and material changes; provide support to raw material changes ensuring Quality Systems are met.
Qualifications
Sr QE : Bachelor’s degree and 5 years of experience within the quality function, or Master’s Degree with a minimum of 3 years in quality.
QEII : Bachelor’s degree; typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields considered with relevant experience. Advanced degree can substitute for experience. 2+ years of experience in Quality Assurance, Quality Control, or product/process non-conformance investigations.
Additional information
At BD, on-site collaboration is prioritized and roles may require a minimum in-office presence per week; remote or field-based arrangements will be indicated in the job posting. Employment may be contingent upon proof of full vaccination against COVID-19 where required by location. BD’s Workplace Accommodations Policy will be followed for applicable requests.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and growth every day.
To learn more about BD, visit our Careers site.
Salary Range Information
$73,300.00 - $121,000.00 USD Annual
Primary Work Location
USA MD - Hunt Valley
BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, familial status, sexual orientation, gender identity or expression, genetics, disability, military status, and other legally protected characteristics.
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