Quality Engineer
Becton Dickinson
Quality Engineer
Job Description
Job Description Summary
Position SummaryPerforms quality assurance activities to ensure compliance with applicable medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Good understanding and frequent application of quality assurance principles, design control concepts, industry practices, and standards. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts.
Educational Background
Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering discipline.
Professional Experience
0-5 years of relevant experience
Job Description
Knowledge and Skills
a. Knowledge
- Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).
- Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry.
- Demonstrated hands-on experience with Design Control procedures.
- Experience in a Phase-Gate development process.
- Experience in directly applying statistical methods for quality improvement.
- Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.
b. Skills
- Good technical writing skills.
- Familiarity with statistical methods and analysis and/or Minitab software.
- Team player with excellent interpersonal and communication skills.
Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
- Familiarity with Six Sigma methodology.
- Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies.
- Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).
- Strong critical thinking, analytical, and problem-solving skills.
Required Skills
Optional Skills
.
Primary Work Location
IND Bengaluru - Technology CampusAdditional Locations
Work Shift
Locations
- Bengaluru, Karnataka, India
Salary
Estimated Salary Rangemedium confidence
600,000 - 1,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- proficiency in technical writingintermediate
- experience with statistical methods and analysisintermediate
- experience with Minitab softwareintermediate
- knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.)intermediate
- experience of Quality or Reliability engineeringintermediate
- experience with risk analysisintermediate
- experience with product developmentintermediate
- experience with verification/validation testingintermediate
- experience with Design Control proceduresintermediate
- experience in a Phase-Gate development processintermediate
- experience in directly applying statistical methods for quality improvementintermediate
- knowledge and understanding of process developmentintermediate
- knowledge of total quality toolsintermediate
- knowledge of continual improvement approachesintermediate
- Familiarity with Six Sigma methodologyintermediate
- Experience in high volume manufacturing and assembly processesintermediate
- experience with plastic injection molded parts and assembliesintermediate
Required Qualifications
- Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering discipline. (degree in mechanical engineering)
- 0-5 years of relevant experience (experience, 5 years)
- Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.). (experience)
- Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry. (experience)
- Demonstrated hands-on experience with Design Control procedures. (experience)
- Experience in a Phase-Gate development process. (experience)
- Experience in directly applying statistical methods for quality improvement. (experience)
- Good knowledge and understanding of process development, total quality tools, and continual improvement approaches. (experience)
Preferred Qualifications
- Familiarity with Six Sigma methodology. (experience)
- Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies. (experience)
- Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods). (experience)
- Strong critical thinking, analytical, and problem-solving skills. (experience)
Responsibilities
- Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements.
- Contributes to the completion of specific programs and projects usually under the direction of a project leader.
Tags & Categories
Quality Engineer
Becton Dickinson
Quality Engineer
Job Description
Job Description Summary
Position SummaryPerforms quality assurance activities to ensure compliance with applicable medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Good understanding and frequent application of quality assurance principles, design control concepts, industry practices, and standards. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts.
Educational Background
Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering discipline.
Professional Experience
0-5 years of relevant experience
Job Description
Knowledge and Skills
a. Knowledge
- Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).
- Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry.
- Demonstrated hands-on experience with Design Control procedures.
- Experience in a Phase-Gate development process.
- Experience in directly applying statistical methods for quality improvement.
- Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.
b. Skills
- Good technical writing skills.
- Familiarity with statistical methods and analysis and/or Minitab software.
- Team player with excellent interpersonal and communication skills.
Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
- Familiarity with Six Sigma methodology.
- Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies.
- Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).
- Strong critical thinking, analytical, and problem-solving skills.
Required Skills
Optional Skills
.
Primary Work Location
IND Bengaluru - Technology CampusAdditional Locations
Work Shift
Locations
- Bengaluru, Karnataka, India
Salary
Estimated Salary Rangemedium confidence
600,000 - 1,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- proficiency in technical writingintermediate
- experience with statistical methods and analysisintermediate
- experience with Minitab softwareintermediate
- knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.)intermediate
- experience of Quality or Reliability engineeringintermediate
- experience with risk analysisintermediate
- experience with product developmentintermediate
- experience with verification/validation testingintermediate
- experience with Design Control proceduresintermediate
- experience in a Phase-Gate development processintermediate
- experience in directly applying statistical methods for quality improvementintermediate
- knowledge and understanding of process developmentintermediate
- knowledge of total quality toolsintermediate
- knowledge of continual improvement approachesintermediate
- Familiarity with Six Sigma methodologyintermediate
- Experience in high volume manufacturing and assembly processesintermediate
- experience with plastic injection molded parts and assembliesintermediate
Required Qualifications
- Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering discipline. (degree in mechanical engineering)
- 0-5 years of relevant experience (experience, 5 years)
- Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.). (experience)
- Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry. (experience)
- Demonstrated hands-on experience with Design Control procedures. (experience)
- Experience in a Phase-Gate development process. (experience)
- Experience in directly applying statistical methods for quality improvement. (experience)
- Good knowledge and understanding of process development, total quality tools, and continual improvement approaches. (experience)
Preferred Qualifications
- Familiarity with Six Sigma methodology. (experience)
- Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies. (experience)
- Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods). (experience)
- Strong critical thinking, analytical, and problem-solving skills. (experience)
Responsibilities
- Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements.
- Contributes to the completion of specific programs and projects usually under the direction of a project leader.
Tags & Categories