Collabera
Product Quality Analyst
Collabera, Santa Ana, California, United States, 92725
About Collabera:
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 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, Disability Insurance.Job Description
Primary Job Function: Responsible for data analysis related to AMO post-market product complaints and reporting on trends to ensure compliance to all applicable Corporate and Divisional policies and procedures. Demonstrates thorough understanding of Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO13485. Actively participates in departmental process improvements and effectively communicates knowledge to contribute to overall success of AMO.Core Job Responsibilities:- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.- Provide Quality Assurance leadership with product quality data and complaint trending to drive product improvements and Corrective and Preventive Actions.- Prepare or assist department leadership with monthly trending reports, annual post-market surveillance reports and other monthly and quarterly reports.- Participate in various process improvement projects.- Responsibilities include developing and reporting on relevant complaint handling system metrics.Works autonomously to identify areas for inquiry. Recognizes that failure to achieve results or erroneous decisions or recommendations may result in significant non-compliance issues. Analyze and report on complaint process metrics.The position is accountable for:- timely and accurate product complaint data analysis and reporting.- developing new and improving existing data analysis tools while maintaining compliance to all regulations.Qualifications
Minimum Education, Experience and Training Required:- Bachelor's degree in a sciences or engineering discipline or similar field or an equivalent combination of education plus work experience.- 1+ years of experience in data analysis, preferably in a regulated medical products manufacturer.- Knowledge of and experience using SQL to construct queries.- Knowledge of and experience using MS Excel to analyze data.- Good verbal and written communication skills.- Ability to work well in a team environment.
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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 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, Disability Insurance.Job Description
Primary Job Function: Responsible for data analysis related to AMO post-market product complaints and reporting on trends to ensure compliance to all applicable Corporate and Divisional policies and procedures. Demonstrates thorough understanding of Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO13485. Actively participates in departmental process improvements and effectively communicates knowledge to contribute to overall success of AMO.Core Job Responsibilities:- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.- Provide Quality Assurance leadership with product quality data and complaint trending to drive product improvements and Corrective and Preventive Actions.- Prepare or assist department leadership with monthly trending reports, annual post-market surveillance reports and other monthly and quarterly reports.- Participate in various process improvement projects.- Responsibilities include developing and reporting on relevant complaint handling system metrics.Works autonomously to identify areas for inquiry. Recognizes that failure to achieve results or erroneous decisions or recommendations may result in significant non-compliance issues. Analyze and report on complaint process metrics.The position is accountable for:- timely and accurate product complaint data analysis and reporting.- developing new and improving existing data analysis tools while maintaining compliance to all regulations.Qualifications
Minimum Education, Experience and Training Required:- Bachelor's degree in a sciences or engineering discipline or similar field or an equivalent combination of education plus work experience.- 1+ years of experience in data analysis, preferably in a regulated medical products manufacturer.- Knowledge of and experience using SQL to construct queries.- Knowledge of and experience using MS Excel to analyze data.- Good verbal and written communication skills.- Ability to work well in a team environment.
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