Manager, Device R&D Quality
DescriptionThis position sits out of our Branchburg, NJ location 3 days weekly; 2 days can be worked remotely.
Purpose:
The primary purpose of this position is to assume a lead role in providing Quality Engineering support for New Product Development projects.
The R&D Quality Manager is responsible for facilitating compliance to applicable internal and external requirements during the product development cycle and commercialization of new products, including ownership of risk assessments, review of design changes and maintenance of Design History Files.
The position will also manage local Quality System processes for Design Control and support the broader R&D Quality team as needed.
Responsibilities:
Perform design control activities:
Mentor/lead product team members through the design process providing guidance.
Work closely with Product Development to ensure potential product issues are identified and addressed in the design.
Assure robust product vs.
customer requirements.
Works with Product Development and Engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.
Work with cross-functional development teams to assist in the development of engineering studies, design verification protocols (including aging), and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
Participate in design reviews and provide expert Quality/technical input to ensure potential problems are identified and corrected early in development to minimize impact to broader project scope/resources/budget.
Assist in the development of validation strategies for performance qualifications and process validations for medical devices and combination products.
Provide expert Quality input for proposed design and/or process changes with respect to impact assessment.
Support/lead root cause investigations and implementation of corrective actions development Maintain and manage the overall site Risk Management process in accordance with ISO 14971 and other applicable standards.
Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure a comprehensive risk management process.
Manage/Support maintenance of Risk Management Files post design transfer.
Support Risk Assessment activities including User-, Design-, and Process- FMEAS in order to proactively identify and mitigate risks through appropriate control strategies and risk mitigation plans.
Perform 3rd party supplier management activities such as review and approval of 3rd party design control activities, assessment of supplier changes, provide input to quality agreements, perform relationship development, supplier site visits, etc.
Support supplier audits as required.
Partner with Third Party Vendors/Manufacturers/Laboratories to ensure that combination products/devices are in compliance with internal and Regulatory Agency standards.
Implement Design Control/Risk Management process improvements to ensure a more effective, efficient, and compliant processes.
Assist with global Quality Process harmonization and improvement efforts.
Provide technical SME input and participate in supplier, customer, internal and/or regulatory agency audits.
Qualifications
Qualifications:
Bachelor s degree in science or engineering.
Minimum of 8 years of quality engineering or related experience in an FDA regulated medical device environment.
Proficiency with medical device development life cycles and Design Control processes required.
Ability to handle complex issues and exercise judgement, based on experience, with minimal oversight from manager.
Knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 Knowledge of IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Skilled in requirements analysis, including testable and measurable specifications.
Familiar with reliability analysis and test methods and test method validation Good verbal (including presentation) and written communication skills, especially technical report writing.
Problem solver.
Six sigma green belt and/or ASQ CQE preferred.
Competent using office software including MS Word, Excel, PowerPoint, and Outlook.
Individuals must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally with internal and external partners and regulatory bodies.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to apply sampling plans and statistical methods for data analysis.
Job Field:
Quality AssuranceJob Type:
ExperiencedOrganization:
Research & DevelopmentSchedule:
Full-timeTravel:
No.
Estimated Salary: $20 to $28 per hour based on qualifications.
Purpose:
The primary purpose of this position is to assume a lead role in providing Quality Engineering support for New Product Development projects.
The R&D Quality Manager is responsible for facilitating compliance to applicable internal and external requirements during the product development cycle and commercialization of new products, including ownership of risk assessments, review of design changes and maintenance of Design History Files.
The position will also manage local Quality System processes for Design Control and support the broader R&D Quality team as needed.
Responsibilities:
Perform design control activities:
Mentor/lead product team members through the design process providing guidance.
Work closely with Product Development to ensure potential product issues are identified and addressed in the design.
Assure robust product vs.
customer requirements.
Works with Product Development and Engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.
Work with cross-functional development teams to assist in the development of engineering studies, design verification protocols (including aging), and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
Participate in design reviews and provide expert Quality/technical input to ensure potential problems are identified and corrected early in development to minimize impact to broader project scope/resources/budget.
Assist in the development of validation strategies for performance qualifications and process validations for medical devices and combination products.
Provide expert Quality input for proposed design and/or process changes with respect to impact assessment.
Support/lead root cause investigations and implementation of corrective actions development Maintain and manage the overall site Risk Management process in accordance with ISO 14971 and other applicable standards.
Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure a comprehensive risk management process.
Manage/Support maintenance of Risk Management Files post design transfer.
Support Risk Assessment activities including User-, Design-, and Process- FMEAS in order to proactively identify and mitigate risks through appropriate control strategies and risk mitigation plans.
Perform 3rd party supplier management activities such as review and approval of 3rd party design control activities, assessment of supplier changes, provide input to quality agreements, perform relationship development, supplier site visits, etc.
Support supplier audits as required.
Partner with Third Party Vendors/Manufacturers/Laboratories to ensure that combination products/devices are in compliance with internal and Regulatory Agency standards.
Implement Design Control/Risk Management process improvements to ensure a more effective, efficient, and compliant processes.
Assist with global Quality Process harmonization and improvement efforts.
Provide technical SME input and participate in supplier, customer, internal and/or regulatory agency audits.
Qualifications
Qualifications:
Bachelor s degree in science or engineering.
Minimum of 8 years of quality engineering or related experience in an FDA regulated medical device environment.
Proficiency with medical device development life cycles and Design Control processes required.
Ability to handle complex issues and exercise judgement, based on experience, with minimal oversight from manager.
Knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 Knowledge of IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Skilled in requirements analysis, including testable and measurable specifications.
Familiar with reliability analysis and test methods and test method validation Good verbal (including presentation) and written communication skills, especially technical report writing.
Problem solver.
Six sigma green belt and/or ASQ CQE preferred.
Competent using office software including MS Word, Excel, PowerPoint, and Outlook.
Individuals must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally with internal and external partners and regulatory bodies.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to apply sampling plans and statistical methods for data analysis.
Job Field:
Quality AssuranceJob Type:
ExperiencedOrganization:
Research & DevelopmentSchedule:
Full-timeTravel:
No.
Estimated Salary: $20 to $28 per hour based on qualifications.
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