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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:

Supplier Development Quality Engineer

St. Paul, Minnesota

Long term contract

Job Description:

Supplier Development Quality Engineer

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:

  • Bachelors Degree ( 16 years) Engineering or Technical Field an equivalent combination of education and work experience
  • Masters Degree ( 18 years) Preferred

Experience Details

  • Minimum 2 years 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 ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 10%, including internationally.

Position Details

POSTED:

Aug 09, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864711463147

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!

Supplier Development Quality Engineer

St. Paul, Minnesota

Long term contract

Job Description:

Supplier Development Quality Engineer

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:

  • Bachelors Degree ( 16 years) Engineering or Technical Field an equivalent combination of education and work experience
  • Masters Degree ( 18 years) Preferred

Experience Details

  • Minimum 2 years 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 ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 10%, including internationally.


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