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Conduct internal audits to ensure the quality system conforms to documented arrangements and regulatory requirements and that is effectively implemented and maintained.
Key Responsibilities :
Prepare the audit plan, to ensure coverage of applicable regulations, processes, and elements according to the audit schedule.
Conduct audits including complex assessments, to ensure conformance with applicable regulations and EW procedures and instruction. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings
Assess previous audit findings to establish strategies and evaluate the effectiveness of the actions taken.
Conduct opening meetings and closure meetings.
Prepare audit documentation including attendance sheets, audit plan and audit report. Ensure documentation is complete, including all objective evidence.
Execute audit considering scope to assure efficient and effective use of scheduled time allocations
Assist in generating metrics for overall auditing system and identify continuous improvement opportunities; may also present metrics to all level of the organization
Other duties assigned by Leadership
Minimum Required
Qualifications:
Bachelor’s Degree with 5 years of quality compliance auditing experience; or Master’s Degree with 3 years of quality compliance auditing experience
ISO 13485 Certified Lead Auditor
Medical device and/or pharmaceutical industry experience
Experience preparing, conducting, and documenting internal audits
In-depth knowledge and working experience with medical device regulations: 21 CFR Part 820, SOR/98/282, RDC 16, MHLW 169, TG 2002, MDSAP, and/or EU MDR 2017/745
Excellent written and verbal communication skills including negotiating and relationship management skills
Strong problem-solving and critical thinking skills
Preferred Qualifications :
Experience with Quality Systems (i.e. CAPAs, NCRs, Field Corrective Actions, etc)
Ability to manage multiple concurrent audits
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan – it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency NoticeEstimated Salary: $20 to $28 per hour based on qualifications.
Key Responsibilities :
Prepare the audit plan, to ensure coverage of applicable regulations, processes, and elements according to the audit schedule.
Conduct audits including complex assessments, to ensure conformance with applicable regulations and EW procedures and instruction. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings
Assess previous audit findings to establish strategies and evaluate the effectiveness of the actions taken.
Conduct opening meetings and closure meetings.
Prepare audit documentation including attendance sheets, audit plan and audit report. Ensure documentation is complete, including all objective evidence.
Execute audit considering scope to assure efficient and effective use of scheduled time allocations
Assist in generating metrics for overall auditing system and identify continuous improvement opportunities; may also present metrics to all level of the organization
Other duties assigned by Leadership
Minimum Required
Qualifications:
Bachelor’s Degree with 5 years of quality compliance auditing experience; or Master’s Degree with 3 years of quality compliance auditing experience
ISO 13485 Certified Lead Auditor
Medical device and/or pharmaceutical industry experience
Experience preparing, conducting, and documenting internal audits
In-depth knowledge and working experience with medical device regulations: 21 CFR Part 820, SOR/98/282, RDC 16, MHLW 169, TG 2002, MDSAP, and/or EU MDR 2017/745
Excellent written and verbal communication skills including negotiating and relationship management skills
Strong problem-solving and critical thinking skills
Preferred Qualifications :
Experience with Quality Systems (i.e. CAPAs, NCRs, Field Corrective Actions, etc)
Ability to manage multiple concurrent audits
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan – it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency NoticeEstimated Salary: $20 to $28 per hour based on qualifications.
