QA AUDITOR 2
QA AUDITOR 2
Posted on :
22-02-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
22-02-2025
Job Description
Primary Function of Position:
Audit Program Manager performs the daytoday administration of all
processes related to internal and external audit. This role ensures that all
Quality audit activities are being performed per *** released
procedures. S/he will ensure effective closure of internal and external audit
findings by working with cross functional and varying level of
departments/business partners to ensure comprehension development and
execution of corrective/preventive action and evaluation of effectiveness
checks. She/he monitors the timely completion of all audit findings related
corrective action plans and coordinates the reporting of compliance metrics.
S/he will support the implementation and continuous improvement of the
quality and regulatory compliance programs (including inspection readiness
programs).
Roles & Responsibilities:
Manage external audit administration activities including coordination
logistics and preparation for external audits
Monitor the audit finding related activities as a result of internal and
external audits to ensure timely completion
Develop and facilitate the reporting of external and internal audit
related metrics to ensure compliance to internal procedure and
external commitments
Execute the governance process to ensure timely and effective reviews
of audit findings and visibility to Senior Management
Promotes a culture of compliance to regulations standards and
procedures and risk management through monitoring and reporting
process
Serve as key liaison for engineering change orders/QMS project
support
Lead and refine the internal audit module including but not limited to:
trouble shooting issues as needed and know when to escalate to IT
partnering with Training LMS Administrator to develop improve and administer Audit Module training provide group or individual training
ensure process changes per documented procedures in Audit Module
Monitors and audits adherence to corporate policies as directed and
investigate any violations including coordinating investigations audits
conducting interviews and preparing reports
Lead other audit management related projects as required
Skills Experience Education & Training:
Minimum Bachelors Degree or equivalent years of experience in
Engineering physical or biological science or other technical field.
A minimum of 23 years of experience in compliance role in the
medical device industry
A working knowledge of project management tools and techniques
Knowledge of EUMDR ISO 13485:2016; Medical Device Single Audit
(MDSAP) and 21 CFR 820 requirements Health Canada and other
international regulatory requirements
Certified Quality Auditor/ISO lead Auditor Certification desired
Demonstrated ability to effectively work with crossfunctional/cross
plant project teams and work effectively with a variety of work groups
Experience interpreting and providing guidance on domestic and
international regulations as applicable to the quality management
system
Strong organizational written and verbal communication skills and the
proven ability to prioritize tasks effectively in a deadlinedriven
environment
Strong interpersonal skills ability to work closely with people at all
levels within the ISI organization and facilitate the implementation of
corrective action
Audit Program Manager performs the daytoday administration of all
processes related to internal and external audit. This role ensures that all
Quality audit activities are being performed per *** released
procedures. S/he will ensure effective closure of internal and external audit
findings by working with cross functional and varying level of
departments/business partners to ensure comprehension development and
execution of corrective/preventive action and evaluation of effectiveness
checks. She/he monitors the timely completion of all audit findings related
corrective action plans and coordinates the reporting of compliance metrics.
S/he will support the implementation and continuous improvement of the
quality and regulatory compliance programs (including inspection readiness
programs).
Roles & Responsibilities:
Manage external audit administration activities including coordination
logistics and preparation for external audits
Monitor the audit finding related activities as a result of internal and
external audits to ensure timely completion
Develop and facilitate the reporting of external and internal audit
related metrics to ensure compliance to internal procedure and
external commitments
Execute the governance process to ensure timely and effective reviews
of audit findings and visibility to Senior Management
Promotes a culture of compliance to regulations standards and
procedures and risk management through monitoring and reporting
process
Serve as key liaison for engineering change orders/QMS project
support
Lead and refine the internal audit module including but not limited to:
trouble shooting issues as needed and know when to escalate to IT
partnering with Training LMS Administrator to develop improve and administer Audit Module training provide group or individual training
ensure process changes per documented procedures in Audit Module
Monitors and audits adherence to corporate policies as directed and
investigate any violations including coordinating investigations audits
conducting interviews and preparing reports
Lead other audit management related projects as required
Skills Experience Education & Training:
Minimum Bachelors Degree or equivalent years of experience in
Engineering physical or biological science or other technical field.
A minimum of 23 years of experience in compliance role in the
medical device industry
A working knowledge of project management tools and techniques
Knowledge of EUMDR ISO 13485:2016; Medical Device Single Audit
(MDSAP) and 21 CFR 820 requirements Health Canada and other
international regulatory requirements
Certified Quality Auditor/ISO lead Auditor Certification desired
Demonstrated ability to effectively work with crossfunctional/cross
plant project teams and work effectively with a variety of work groups
Experience interpreting and providing guidance on domestic and
international regulations as applicable to the quality management
system
Strong organizational written and verbal communication skills and the
proven ability to prioritize tasks effectively in a deadlinedriven
environment
Strong interpersonal skills ability to work closely with people at all
levels within the ISI organization and facilitate the implementation of
corrective action
Employment Type
Full Time
Key Skills
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