Quality Control Engineer
As the Quality Engineer, you will support Rhythmlink product portfolios for our global market.
You will be responsible for enabling global product sales by maintaining registration status throughout product lifecycles, advocating for relevant functions of the Quality Management System, and execution of activities related to equipment and software qualification and validation and quality control technical expertise.
You will liaise with internal and external customers and establish strong relationships with Rhythmlink suppliers, customers, and personnel.
Essential Functions (Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics.
This list of tasks is not a comprehensive listing of all functions and tasks performed by this position.
It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.
) Software Validation:
Coordinate software system installation and monitor software/equipment functioning to ensure operational specifications are met.
Develop risk appropriate test protocols including user requirements for software utilized in QMS.
Monitor and document appropriately software upgrades to existing software Maintain the Software Validation Matrix Work with IT team or outside vendors to modify existing software to correct errors, to adapt to new hardware, or to improve its performance.
QMS Maintenance Manage equipment Preventative Maintenance and Calibration program at Rhythmlink, including managing the master validation plan for products.
Remediation and/or maintenance of technical documentation to State of the Art, where required.
Analyzes quality data and provide compliant, pragmatic guidance to support regulatory compliance activities including responses to agency requests for information and analyses to support quality KPI's and improvement projects.
Participate in internal or external audits or regulatory inspections across global sites.
Conduct projects and assignments with technical responsibility.
Specifications/Validations Develop product specifications, inspection plans, test methods to align with current procedural requirements, contract manufacturing requirements including ANSI sampling methodology.
Develop laboratory test procedures, perform and/or oversee test method validation and execution of testing.
CAPA / NC:
Escalate opportunities for Corrective and Preventive action, assist with investigation/resolution, and confirm effectiveness when required.
Manage quality complaint investigations and resolve CAPAs identified in areas of responsibility.
Manage technical sample review for complaint samples and non-conforming samples.
Supplier Quality Support supplier quality program, including but not limited to developing testing plans and product specifications.
Problem solving of technical issues related to design, development, and manufacturing supporting complaint, CAPA and SCAR investigations.
Knowledge, Skills, and Abilities Knowledge of ISO 13485 and 21 CFR 820 Strong analytical, problem solving and technical writing skill Ability to work with a variety of disciplines and levels of staff both internally and externally Ability to work independently or as an integral part of a cross-functional team Able to understand, interpret, explain, and resolve technical issues Strong project management and organizational skills Education, Training, and Experience Bachelor's Degree required, a degree in Engineering preferred Prior experience with medical devices required Experience with statistical analysis and associated software Preferred Education and/or
Experience:
Certified Quality Engineer and/or Certified Reliability Engineer Lean Six Sigma Green Belt or Black Belt Certified Project Manager Recommended Skills Analytical Blackbelt Calibration Certified Quality Engineer Certified Reliability Engineer Coordinating Estimated Salary: $20 to $28 per hour based on qualifications.
You will be responsible for enabling global product sales by maintaining registration status throughout product lifecycles, advocating for relevant functions of the Quality Management System, and execution of activities related to equipment and software qualification and validation and quality control technical expertise.
You will liaise with internal and external customers and establish strong relationships with Rhythmlink suppliers, customers, and personnel.
Essential Functions (Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics.
This list of tasks is not a comprehensive listing of all functions and tasks performed by this position.
It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.
) Software Validation:
Coordinate software system installation and monitor software/equipment functioning to ensure operational specifications are met.
Develop risk appropriate test protocols including user requirements for software utilized in QMS.
Monitor and document appropriately software upgrades to existing software Maintain the Software Validation Matrix Work with IT team or outside vendors to modify existing software to correct errors, to adapt to new hardware, or to improve its performance.
QMS Maintenance Manage equipment Preventative Maintenance and Calibration program at Rhythmlink, including managing the master validation plan for products.
Remediation and/or maintenance of technical documentation to State of the Art, where required.
Analyzes quality data and provide compliant, pragmatic guidance to support regulatory compliance activities including responses to agency requests for information and analyses to support quality KPI's and improvement projects.
Participate in internal or external audits or regulatory inspections across global sites.
Conduct projects and assignments with technical responsibility.
Specifications/Validations Develop product specifications, inspection plans, test methods to align with current procedural requirements, contract manufacturing requirements including ANSI sampling methodology.
Develop laboratory test procedures, perform and/or oversee test method validation and execution of testing.
CAPA / NC:
Escalate opportunities for Corrective and Preventive action, assist with investigation/resolution, and confirm effectiveness when required.
Manage quality complaint investigations and resolve CAPAs identified in areas of responsibility.
Manage technical sample review for complaint samples and non-conforming samples.
Supplier Quality Support supplier quality program, including but not limited to developing testing plans and product specifications.
Problem solving of technical issues related to design, development, and manufacturing supporting complaint, CAPA and SCAR investigations.
Knowledge, Skills, and Abilities Knowledge of ISO 13485 and 21 CFR 820 Strong analytical, problem solving and technical writing skill Ability to work with a variety of disciplines and levels of staff both internally and externally Ability to work independently or as an integral part of a cross-functional team Able to understand, interpret, explain, and resolve technical issues Strong project management and organizational skills Education, Training, and Experience Bachelor's Degree required, a degree in Engineering preferred Prior experience with medical devices required Experience with statistical analysis and associated software Preferred Education and/or
Experience:
Certified Quality Engineer and/or Certified Reliability Engineer Lean Six Sigma Green Belt or Black Belt Certified Project Manager Recommended Skills Analytical Blackbelt Calibration Certified Quality Engineer Certified Reliability Engineer Coordinating Estimated Salary: $20 to $28 per hour based on qualifications.
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