Senior Quality Engineer
A$ A' A' ?REQUIREMENTSInvestigating, identifying, and implementing current Quality Engineering practices.
Providing focused quality engineering support and assuming responsibility for timely and effective coordination and/or execution of assigned development project activities.
Establishing effective corrective action plans.
Leading in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Reviewing and approving product and process qualification and validation and other change control related documentation.
Developing product/process assurance plans, which include all required elements.
Identifying and implementing effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirementsGenerating internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
Participating in Product Review Boards.
Identify non-conformance trends and develop technical investigation plans.
Investigates and analyze customer/internal complaints.
Performing analytical measurements and experiments to qualify or resolve product and process issues.
Responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.
Tracking quality trends and initiate action items to resolve issues.
Managing assigned corrective actions.
Monitoring field quality and analyze field returns to determine root cause.
Providing training and support for quality system processes and quality engineering practices.
QUALIFICATIONSMinimum 8 - 10
years' experience in a medical device quality assurance environment.
Auditing experience is a plusUnderstanding in Control Plans, PFMEA, and DFMEA experienceCAPA and Statistical experienceCommunication skills both verbal and written.
Organizational skills as well as time management skills essential for project work.
Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.
Excellent computer skillsStrong writing, mathematics, and statistics skillsEDUCATIONBachelor's degree in engineering, life sciences, or related discipline.
Estimated Salary: $20 to $28 per hour based on qualifications.
Providing focused quality engineering support and assuming responsibility for timely and effective coordination and/or execution of assigned development project activities.
Establishing effective corrective action plans.
Leading in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Reviewing and approving product and process qualification and validation and other change control related documentation.
Developing product/process assurance plans, which include all required elements.
Identifying and implementing effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirementsGenerating internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
Participating in Product Review Boards.
Identify non-conformance trends and develop technical investigation plans.
Investigates and analyze customer/internal complaints.
Performing analytical measurements and experiments to qualify or resolve product and process issues.
Responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.
Tracking quality trends and initiate action items to resolve issues.
Managing assigned corrective actions.
Monitoring field quality and analyze field returns to determine root cause.
Providing training and support for quality system processes and quality engineering practices.
QUALIFICATIONSMinimum 8 - 10
years' experience in a medical device quality assurance environment.
Auditing experience is a plusUnderstanding in Control Plans, PFMEA, and DFMEA experienceCAPA and Statistical experienceCommunication skills both verbal and written.
Organizational skills as well as time management skills essential for project work.
Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.
Excellent computer skillsStrong writing, mathematics, and statistics skillsEDUCATIONBachelor's degree in engineering, life sciences, or related discipline.
Estimated Salary: $20 to $28 per hour based on qualifications.
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