The #1 Site for IT and Engineering Jobs - search all IT and Engineering  jobs.
Mjp1vl6v1qfgrqpyz7r

Quality Engineer- QMS

Job Description

Title:                   Quality Engineer- QMS 

Location:            Neenah WI 54956

Duration:           12 Months (contract to Hire)

Hours :               8:00am to 5:00pm

Description 

  • Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.
  • Manages self and/or team in accordance with the expected behaviors of the Leadership Qualities. Effectively achieve results that meet business and individual objectives.
  • Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
  • Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
  • Performs production and quality systems audits.
  • Develops and implements support systems and processes for managing quality records and documents that meet both internal and external requirements.
  • Maintain and demonstrate an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations.
  • Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.
  • Executes continuous improvement activities for established processes and initiates development of new processes.
  • Builds and maintains capability in K-C QMS, Standards, and Regulations (FDA, Health Canada) to support objectives.


Job Requirements

Position Specific Accountabilities:

  • Act as the system owner of one or more critical/high-risk quality systems (CAPA/QNC, Internal Audits, Audit Readiness), making decisions on changes to standards, auditing system users (including Quality, R&E, Mills, and other enterprise functions) for compliance to standards, training users on the standards, and supporting targeted implementation as needed to deliver business results.
  • Identifies need for, develops, and executes continuous improvement plans for the assigned systems.
  • Builds and maintains capability within the assigned systems for compliance with K-C QMS, Industry Standards, and Regulations.
  • Initiates and executes continuous improvement activities for established processes, and supports development of new processes.
  • Provides Quality System technical expertise and/or support to business, suppliers and other functional teams.
  • Assists in the development and implementation of new quality concepts to improve the way business, facilities, and support functions perform duties to achieve Quality objectives.
  • Initiates and follows up on CAPA and QNC related to the assigned systems.

Scope:

  • This position reports to NA Sr. Quality Manager. Has responsibility for assigned customers as well as assisting with other customers. Assists in or leads moderate to large sized projects. Plans and carries out customer service and project responsibilities with minimal direction but asks for assistance/guidance when appropriate.
  • Qualifications/Education/Experience Required:
  • Normally requires a bachelor’s degree in science, engineering or related discipline and 8+ years of broad experience in a Quality, Manufacturing, Research or Regulatory function. Experience should include close working relationships with customer functions, good breadth of knowledge of applicable FDA, Health Canada, and K-C QMS requirements for formulated cosmetics and medical devices, technical quality skills in the applicable or related system area, demonstrated application of LEAN/ Continuous Improvement skills, and demonstrated skill as a trainer. Requires prior leadership experience with moderate to large sized projects or systems.
  • Six Sigma Certified Black or Green Belt, ASQ-Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager and ISO 9001 or 13485 Lead Auditor Certification is preferred.
  • Strong analytical skills including trend and statistical analysis.

Job Snapshot

Location US-WI-Neenah
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Other
Apply

Company Overview

American Cybersystems, Inc. (ACS Group)

ACS Group provides services to Fortune 1000 companies across various industry verticals. With a proven track record of managing project demands while improving the efficiency, productivity and profitability of new and existing projects through process improvement, ACS Group is consistently recognized for identifying and implementing strategic solutions that create and preserve long-term business value. Learn More

Contact Information

US-WI-Neenah
Mayank Kumar
7702557926
Icon-social-facebookIcon-social-linkedinIcon-social-twitter
Snapshot
American Cybersystems, Inc. (ACS Group)
Company:
US-WI-Neenah
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

Title:                   Quality Engineer- QMS 

Location:            Neenah WI 54956

Duration:           12 Months (contract to Hire)

Hours :               8:00am to 5:00pm

Description 

  • Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.
  • Manages self and/or team in accordance with the expected behaviors of the Leadership Qualities. Effectively achieve results that meet business and individual objectives.
  • Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
  • Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
  • Performs production and quality systems audits.
  • Develops and implements support systems and processes for managing quality records and documents that meet both internal and external requirements.
  • Maintain and demonstrate an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations.
  • Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.
  • Executes continuous improvement activities for established processes and initiates development of new processes.
  • Builds and maintains capability in K-C QMS, Standards, and Regulations (FDA, Health Canada) to support objectives.


Job Requirements

Position Specific Accountabilities:

  • Act as the system owner of one or more critical/high-risk quality systems (CAPA/QNC, Internal Audits, Audit Readiness), making decisions on changes to standards, auditing system users (including Quality, R&E, Mills, and other enterprise functions) for compliance to standards, training users on the standards, and supporting targeted implementation as needed to deliver business results.
  • Identifies need for, develops, and executes continuous improvement plans for the assigned systems.
  • Builds and maintains capability within the assigned systems for compliance with K-C QMS, Industry Standards, and Regulations.
  • Initiates and executes continuous improvement activities for established processes, and supports development of new processes.
  • Provides Quality System technical expertise and/or support to business, suppliers and other functional teams.
  • Assists in the development and implementation of new quality concepts to improve the way business, facilities, and support functions perform duties to achieve Quality objectives.
  • Initiates and follows up on CAPA and QNC related to the assigned systems.

Scope:

  • This position reports to NA Sr. Quality Manager. Has responsibility for assigned customers as well as assisting with other customers. Assists in or leads moderate to large sized projects. Plans and carries out customer service and project responsibilities with minimal direction but asks for assistance/guidance when appropriate.
  • Qualifications/Education/Experience Required:
  • Normally requires a bachelor’s degree in science, engineering or related discipline and 8+ years of broad experience in a Quality, Manufacturing, Research or Regulatory function. Experience should include close working relationships with customer functions, good breadth of knowledge of applicable FDA, Health Canada, and K-C QMS requirements for formulated cosmetics and medical devices, technical quality skills in the applicable or related system area, demonstrated application of LEAN/ Continuous Improvement skills, and demonstrated skill as a trainer. Requires prior leadership experience with moderate to large sized projects or systems.
  • Six Sigma Certified Black or Green Belt, ASQ-Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager and ISO 9001 or 13485 Lead Auditor Certification is preferred.
  • Strong analytical skills including trend and statistical analysis.
Sologig Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using sologig.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
Quality Engineer- QMS Apply now