Quality Engineer

Job Opening for Quality Engineer, Florida, Client: Cardinal Health - Onsite Req#: 15556458
Name: Quality Engineer
Type: Staffing
Status: Pending
Client: Cardinal Health
Start: 03/21/2022
End: 09/30/2022

Description:
Department: 7900000075 Tampa NON INVASIVE PRODUCTION - OVH Job Category: QRA and Engineering Job Title: Quality Engineer
Duties: This position will lead changes, integrate systems and mitigate risks associated with the electronic Device History Record (eDHR) project implementation.

Demonstrates understanding of quality regulations & standards, principles, systems, methods and tools.
Develops and implements quality process improvement systems, including tracking, analyzing, reporting and problem solving.
Experience working with document changes, manufacturing work instructions and device history records (DHRs).
Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.
Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.
Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.

Skills: Experience working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA, cGMP, and Risk Management (ISO 14971).
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
May contribute to the development of policies and procedures.
Works on complex projects of large scope.
Develops technical solutions to a wide range of difficult problems.
Solutions are innovative and consistent with organization objectives.
Completes work independently receives general guidance on new projects.
May act as a mentor to less experienced colleagues.
Excellent time management.
Must be able to multi?task and operate in a fast-paced environment with minimal training and supervision.
Strong written, verbal, and interpersonal skills.

Experience with eDHR, Document Control Changes, audits, CAPA and Supplier Quality preferred.
Education: Bachelors degree in related field required, preferably Engineering.
3 - 5 years experience in related industry, with previous medical device experience preferred.

Job Opening for Quality Engineer, Florida, Client: Cardinal Health - Onsite Req#: 15556458
Name: Quality Engineer
Type: Staffing
Status: Pending
Client: Cardinal Health
Start: 03/21/2022
End: 09/30/2022

Description:
Department: 7900000075 Tampa NON INVASIVE PRODUCTION - OVH Job Category: QRA and Engineering Job Title: Quality Engineer
Duties: This position will lead changes, integrate systems and mitigate risks associated with the electronic Device History Record (eDHR) project implementation.

Demonstrates understanding of quality regulations & standards, principles, systems, methods and tools.
Develops and implements quality process improvement systems, including tracking, analyzing, reporting and problem solving.
Experience working with document changes, manufacturing work instructions and device history records (DHRs).
Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.
Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.
Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.

Skills: Experience working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA, cGMP, and Risk Management (ISO 14971).
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
May contribute to the development of policies and procedures.
Works on complex projects of large scope.
Develops technical solutions to a wide range of difficult problems.
Solutions are innovative and consistent with organization objectives.
Completes work independently receives general guidance on new projects.
May act as a mentor to less experienced colleagues.
Excellent time management.
Must be able to multi?task and operate in a fast-paced environment with minimal training and supervision.
Strong written, verbal, and interpersonal skills.

Experience with eDHR, Document Control Changes, audits, CAPA and Supplier Quality preferred.
Education: Bachelors degree in related field required, preferably Engineering.
3 - 5 years experience in related industry, with previous medical device experience preferred.