Collabera
CAPA Compliance Quality Specialist
Collabera, North Haven, Connecticut, us, 06473
Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace.
With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including:
Collabera awarded Best Staffing Company to work for in 2012 by SIA.Collabera listed in GS 100 - recognized for excellence and maturity.Collabera named among the Top 500 Diversity Owned Businesses.Collabera listed in GS 100 & ranked among top 10 service providers.Collabera was ranked:32 in the Top 100 Large Businesses in the U.S.18 in Top 500 Diversity Owned Businesses in the U.S.3 in the Top 100 Diversity Owned Businesses in New Jersey.3 in the Top 100 Privately-held Businesses in New Jersey.66th on FinTech 100.35th among top private companies in New Jersey.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
Summary of Position:Develops and manages the process that establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.Essential Functions: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.Additional Information
To know more about this opportunity, please contact:
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With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including:
Collabera awarded Best Staffing Company to work for in 2012 by SIA.Collabera listed in GS 100 - recognized for excellence and maturity.Collabera named among the Top 500 Diversity Owned Businesses.Collabera listed in GS 100 & ranked among top 10 service providers.Collabera was ranked:32 in the Top 100 Large Businesses in the U.S.18 in Top 500 Diversity Owned Businesses in the U.S.3 in the Top 100 Diversity Owned Businesses in New Jersey.3 in the Top 100 Privately-held Businesses in New Jersey.66th on FinTech 100.35th among top private companies in New Jersey.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
Summary of Position:Develops and manages the process that establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.Essential Functions: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.Additional Information
To know more about this opportunity, please contact:
#J-18808-Ljbffr