Collabera
Compliance Audit Analyst
Collabera, Carlsbad, California, United States, 92002
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.Collabera recognizes the true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, and Disability Insurance.Job Description
Manage CAPA workstream, CAPA investigations, CAPA & compliance audit trending of quality data streams.Develop & establish continuously improving plans for site CAPA system, quality assurance programs & quality policies.Plan, schedule & execute internal quality audits program for ventilation design sites.Lead a team of auditor(s) to perform audits/assessments by collecting and analyzing objective evidence regarding issues and risks. Report findings (verbally and written) to management.Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate.Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.Develop and maintain compliance policies supporting the Respiratory and Monitoring quality system.Lead process improvement projects and conduct training with Quality to improve the GBUs overall quality system compliance.Assist with site regulatory compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations.Maintain working knowledge of existing and proposed domestic and international medical device regulations and guidance documents and their impact on Medtronic's operations.Prepare management reports depicting trends and useful data for management review purposes.Support management during external inspections and participate in the management of external inspections as required.Qualifications
Auditing experience to the 21CFR820.30, 21CFR820.100, ISO13485, ISO 14971:2012, CMDR and the Medical Device Directive.Formal training in CAPA compliance & Investigation techniques.
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Manage CAPA workstream, CAPA investigations, CAPA & compliance audit trending of quality data streams.Develop & establish continuously improving plans for site CAPA system, quality assurance programs & quality policies.Plan, schedule & execute internal quality audits program for ventilation design sites.Lead a team of auditor(s) to perform audits/assessments by collecting and analyzing objective evidence regarding issues and risks. Report findings (verbally and written) to management.Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate.Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.Develop and maintain compliance policies supporting the Respiratory and Monitoring quality system.Lead process improvement projects and conduct training with Quality to improve the GBUs overall quality system compliance.Assist with site regulatory compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations.Maintain working knowledge of existing and proposed domestic and international medical device regulations and guidance documents and their impact on Medtronic's operations.Prepare management reports depicting trends and useful data for management review purposes.Support management during external inspections and participate in the management of external inspections as required.Qualifications
Auditing experience to the 21CFR820.30, 21CFR820.100, ISO13485, ISO 14971:2012, CMDR and the Medical Device Directive.Formal training in CAPA compliance & Investigation techniques.
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