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Supplier Development Quality Engineer

In Minnesota / United States

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Supplier Development Quality Engineer   

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JOB TITLE:

Supplier Development Quality Engineer

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Saint Paul Minnesota / United States

JOB DESCRIPTION:

Hello,

This is Venkat from Intellectt Inc. Please find the below position and let me know your response.

Role: Supplier Development Quality Engineer

Location: St. Paul, MN

Duration: 24+ Months on W2

Description:

A Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Main Responsibility:

  • Execute and support on-time completion of Design Control Deliverables
  • Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead or support Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support internal & external audit responses
  • Support product re-certifications
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support execution of biocompatibility and sterilization qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications:

Bachelor's Degree in Engineering or Technical Field or an equivalent combination of education and work experience

Experience:

  • Minimum 2+ years in Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Multitasks prioritizes and meets deadlines in a timely manner. Strong organizational and follow-up skills, as well as attention to detail.

Position Details

POSTED:

Jun 23, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864709373144

LOCATION:

Minnesota / United States

CITY:

Saint Paul

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Supplier Development Quality Engineer    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Hello,

This is Venkat from Intellectt Inc. Please find the below position and let me know your response.

Role: Supplier Development Quality Engineer

Location: St. Paul, MN

Duration: 24+ Months on W2

Description:

A Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Main Responsibility:

  • Execute and support on-time completion of Design Control Deliverables
  • Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead or support Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support internal & external audit responses
  • Support product re-certifications
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support execution of biocompatibility and sterilization qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications:

Bachelor's Degree in Engineering or Technical Field or an equivalent combination of education and work experience

Experience:

  • Minimum 2+ years in Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Multitasks prioritizes and meets deadlines in a timely manner. Strong organizational and follow-up skills, as well as attention to detail.


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