quality assurance manager in briarcliff manor

posted
contact
terri miniutti, tatum executive services
job type
permanent
salary
US$ 85,000 - US$ 95,000 per year
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job details

posted
location
briarcliff manor, new york
job category
Warehousing & Distribution
job type
permanent
working hours
9 to 5
salary
US$ 85,000 - US$ 95,000 per year
experience
4 Years
reference number
500722
contact
terri miniutti, tatum executive services
phone
612-313-7941

job description

job summary:

The Quality Assurance Manager is responsible for the implementation and maintenance of the Quality Management Systems including processes, procedures and policies required to manage and control facility to ensure compliance ISO 9001, Good Manufacturing and Distribution Practices (GMDP) and national/ international regulations and requirements. Experience in ISO 9001 and AS-91000 is critical for this role.

RESPONSIBILITIES

  • Implement, communicate and maintain Quality System and Policies
  • Performs and supervises the performance of physical inspections which provide monitoring products including inspection incoming materials, work in process and final inspection before shipping.
  • Define standards and quality processes and procedures throughout effective controlled documents
  • Responsible for the issue and control of quality documents including the Quality Manual, Standard Procedures, and Formal Work Instructions
  • Write quality assurance procedures as required for GMDP compliance
  • Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated CAPA - Corrective and Preventive Actions
  • Oversee and review quality issue reporting, resolution and follow up, including completion of Client Issue Reports and insure effectiveness checks are performed
  • Prepare an external audit program and perform audits of external service providers as part of the vendor's selection process;
  • Host client audits and regulatory inspections and manage the audit report responses;
  • Manage CAPA plans up completion and effectiveness and implement quality improvements initiatives;
  • Ensure the local implementation of Technical Quality Agreements and compliance with requirements described into the documents;
  • Assist with the collection of Key Performance Indicator (KPI) data and reporting and the production of KPI metrics to monitor and drive continuous improvement within the Branch
  • Maintain general Quality, Health and Safety standards within the branch
  • Define and execute training to improve understanding of and compliance with procedures and quality requirements

REQUIREMENTS:

  • Bachelor's degree and 7 years of experience in Quality Assurance or. equivalent combination of relevant education and professional experience.
  • Strong knowledge of process improvement methods using statistical techniques
  • Blueprint Reading: read and interpret customers' blueprints and specifications proficiently
  • Tooling / Gauging: dimensional tools - e.g. calipers, micrometers, optical comparator, Sunnen gauges, CMM machine.
  • Excellent mathematical, computer, and communication skills
  • ISO 9001:2015 and AS9100 experience - certification a plus
  • Experience with Pre-Production approval Process (PPAP) and Failure Mode Effects Analysis (FMEA)
  • Six Sigma - Black Belt or Green Belt
  • Route Cause Analysis
  • Experience working in a GMP and GDP environment. Senior or Lead Auditor experience in self inspections, internal and external audits
  • Excellent Compensation Program including generous base salary, Medical/Dental/Vision/401K, PTO, Holidays, etc.
 
location: Briarcliff Manor, New York
job type: Permanent
salary: $85,000 - 95,000 per year
work hours: 9 to 5
education: Bachelor's degree
experience: 4 Years
 
responsibilities:
  • Implement, communicate and maintain Quality System and Policies
  • Performs and supervises the performance of physical inspections which provide monitoring products including inspection incoming materials, work in process and final inspection before shipping.
  • Define standards and quality processes and procedures throughout effective controlled documents
  • Responsible for the issue and control of quality documents including the Quality Manual, Standard Procedures, and Formal Work Instructions
  • Write quality assurance procedures as required for GMDP compliance
  • Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated CAPA - Corrective and Preventive Actions
  • Oversee and review quality issue reporting, resolution and follow up, including completion of Client Issue Reports and insure effectiveness checks are performed
  • Prepare an external audit program and perform audits of external service providers as part of the vendor's selection process;
  • Host client audits and regulatory inspections and manage the audit report responses;
  • Manage CAPA plans up completion and effectiveness and implement quality improvements initiatives;
  • Ensure the local implementation of Technical Quality Agreements and compliance with requirements described into the documents;
  • Assist with the collection of Key Performance Indicator (KPI) data and reporting and the production of KPI metrics to monitor and drive continuous improvement within the Branch
  • Maintain general Quality, Health and Safety standards within the branch
  • Define and execute training to improve understanding of and compliance with procedures and quality requirements
 
qualifications:

.

  • Bachelor's degree and 7 years of experience in Quality Assurance or. equivalent combination of relevant education and professional experience.
  • Strong knowledge of process improvement methods using statistical techniques
  • Blueprint Reading: read and interpret customers' blueprints and specifications proficiently
  • Tooling / Gauging: dimensional tools - e.g. calipers, micrometers, optical comparator, Sunnen gauges, CMM machine.
  • Excellent mathematical, computer, and communication skills
  • ISO 9001:2015 and AS9100 experience - certification a plus
  • Experience with Pre-Production approval Process (PPAP) and Failure Mode Effects Analysis (FMEA)
  • Six Sigma - Black Belt or Green Belt
  • Route Cause Analysis
  • Experience working in a GMP and GDP environment. Senior or Lead Auditor experience in self inspections, internal and external audits
  • Excellent Compensation Program including generous base salary, Medical/Dental/Vision/401K, PTO, Holidays, etc.
 
skills: Vendor Relations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

skills

Vendor Relations

qualification

.

  • Bachelor’s degree and 7 years of experience in Quality Assurance or. equivalent combination of relevant education and professional experience.
  • Strong knowledge of process improvement methods using statistical techniques
  • Blueprint Reading: read and interpret customers’ blueprints and specifications proficiently
  • Tooling / Gauging:  dimensional tools – e.g. calipers, micrometers, optical comparator, Sunnen gauges, CMM machine.
  • Excellent mathematical, computer, and communication skills
  • ISO 9001:2015 and AS9100 experience – certification a plus
  • Experience with Pre-Production approval Process (PPAP) and Failure Mode Effects Analysis (FMEA)
  • Six Sigma – Black Belt or Green Belt
  • Route Cause Analysis
  • Experience working in a GMP and GDP environment.  Senior or Lead Auditor experience in self inspections, internal and external audits 
  • Excellent Compensation Program including generous base salary, Medical/Dental/Vision/401K, PTO, Holidays, etc.

responsibilities

  • Implement, communicate and maintain Quality System and  Policies
  • Performs and supervises the performance of physical inspections which provide monitoring products including inspection incoming materials, work in process and final   inspection before shipping.
  • Define standards and quality processes and procedures throughout effective controlled documents
  • Responsible for the issue and control of quality documents including the Quality Manual, Standard Procedures, and Formal Work Instructions
  • Write quality assurance procedures as required for GMDP compliance
  • Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated CAPA - Corrective and Preventive Actions
  • Oversee and review quality issue reporting, resolution  and follow up, including completion of Client Issue Reports and insure effectiveness checks are performed
  • Prepare an external audit program and perform audits of external service providers as part of the vendor’s selection process;
  • Host client audits and regulatory inspections and manage the audit report responses;
  • Manage CAPA plans up completion and effectiveness and implement quality improvements initiatives;
  • Ensure the local implementation of Technical Quality Agreements and compliance with requirements described into the documents;
  • Assist with the collection of Key Performance Indicator (KPI) data and reporting and the production of KPI metrics to monitor and drive continuous improvement within the Branch
  • Maintain general Quality, Health and Safety standards within the branch
  • Define and execute training to improve understanding of and compliance with procedures and quality requirements

educational requirements

Bachelor's degree