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Quality Systems Specialist

Job Description

Senior Quality Systems Specialist Contractor
Tucson, AZ (campus most likely still remote through the end of the year)

Initial 3-month contract (w2 only)

 This position is responsible for performing compliance activities with limited supervision, including but not limited to Post Launch Review (PLR) and IVDR Post market surveillancereporting. This position will work closely with the Regulatory Compliance and/or Quality Manager and multiple business areas to complete the PLRs and IVDR Post market surveillance. Responsibilities Assists with the maintenance of processes/procedures for ensuring compliance to internal and external requirements.  Provides compliance support for manufacturing, R&D, Quality Assurance, and Operations as required to assure regulatory compliance and appropriate business planning.  Supports communications with scientific and Regulatory bodies as necessary. Maintains regulatory compliance controlled document archives as directed.  Constructs and distributes minutes associated with Post Launch review (PLR) and IVDR Post market surveillance meetings  Works with management to help create and analyze trends from product performance.  Creates required summary reports and processes them along with supporting data in the site's Document Control System.  Resolves issues affecting report approval.
  • Participates in, and where necessary, drives the continuous improvement of the quality processes.
  Helps monitor work to ensure quality, and continuously promote Quality First Time.  Internal support for review of policies and procedures to ensure compliance with government regulations and international Quality System Regulations (QSR) including quality system standards such as 21 CFR Parts 803, 806, 820 and ISO 13485/9000 and ISO 14971 etc.  May perform other duties as required or assigned. QUALIFICATIONSTo perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.Formal Training/EducationEducation LevelEducation DetailsReqPref Bachelor's DegreeB.S./B.A. in biological or life science, engineering or related field or equivalent combination of education and related experience.X    Are equivalencies acceptable?N• (MUST HAVE AT LEAST A BS/BA Degree)ExperienceYears of ExperienceExperience DetailsReqPref 5 yearsMinimum of 5 years' experience in the Medical Device/Pharmaceutical Industry, preferably with IVDs. X 1 yearAt least 1 year previous experience with domestic and international regulations.X   
Experience continued: 
  • Knowledge of change control and document management systems
  • Solid understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
  • Able to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
  • Knowledge of word processing and spreadsheets.
Other info: personality fit the manager is looking for: 
  • Solid understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
  • Solid understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
  • Strong reasoning, interpersonal and organizational skills. Displaying a high degree of accuracy and quality.
  • Ability to work in past paced setting and cross-functionally with all levels of employees.
  • Excellent oral and written communication skills. Ability to prepare and present information to groups.
  • High degree of initiative with the ability to work independently

Job Requirements

 

Job Snapshot

Location US-AZ-Tucson
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Other
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-AZ-Tucson
Afreen Naaz
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Snapshot
Ascent
Company:
US-AZ-Tucson
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

Senior Quality Systems Specialist Contractor
Tucson, AZ (campus most likely still remote through the end of the year)

Initial 3-month contract (w2 only)

 This position is responsible for performing compliance activities with limited supervision, including but not limited to Post Launch Review (PLR) and IVDR Post market surveillancereporting. This position will work closely with the Regulatory Compliance and/or Quality Manager and multiple business areas to complete the PLRs and IVDR Post market surveillance. Responsibilities Assists with the maintenance of processes/procedures for ensuring compliance to internal and external requirements.  Provides compliance support for manufacturing, R&D, Quality Assurance, and Operations as required to assure regulatory compliance and appropriate business planning.  Supports communications with scientific and Regulatory bodies as necessary. Maintains regulatory compliance controlled document archives as directed.  Constructs and distributes minutes associated with Post Launch review (PLR) and IVDR Post market surveillance meetings  Works with management to help create and analyze trends from product performance.  Creates required summary reports and processes them along with supporting data in the site's Document Control System.  Resolves issues affecting report approval.
  • Participates in, and where necessary, drives the continuous improvement of the quality processes.
  Helps monitor work to ensure quality, and continuously promote Quality First Time.  Internal support for review of policies and procedures to ensure compliance with government regulations and international Quality System Regulations (QSR) including quality system standards such as 21 CFR Parts 803, 806, 820 and ISO 13485/9000 and ISO 14971 etc.  May perform other duties as required or assigned. QUALIFICATIONSTo perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.Formal Training/EducationEducation LevelEducation DetailsReqPref Bachelor's DegreeB.S./B.A. in biological or life science, engineering or related field or equivalent combination of education and related experience.X    Are equivalencies acceptable?N• (MUST HAVE AT LEAST A BS/BA Degree)ExperienceYears of ExperienceExperience DetailsReqPref 5 yearsMinimum of 5 years' experience in the Medical Device/Pharmaceutical Industry, preferably with IVDs. X 1 yearAt least 1 year previous experience with domestic and international regulations.X   
Experience continued: 
  • Knowledge of change control and document management systems
  • Solid understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
  • Able to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
  • Knowledge of word processing and spreadsheets.
Other info: personality fit the manager is looking for: 
  • Solid understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
  • Solid understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
  • Strong reasoning, interpersonal and organizational skills. Displaying a high degree of accuracy and quality.
  • Ability to work in past paced setting and cross-functionally with all levels of employees.
  • Excellent oral and written communication skills. Ability to prepare and present information to groups.
  • High degree of initiative with the ability to work independently

Job Requirements

 
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Quality Systems Specialist Apply now