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Quality Engineer (2 Openings)

DivIHN Integration Inc

Plymouth, MN • On-site

$76K - $98K/yr

Contractor

Re-posted 3 days ago

Job description

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.

 
Please apply or call one of us to learn more

For further inquiries regarding the following opportunity, please contact one of our Talent Specialists:
Hema Malini at (630) 847 0275
Meghna at (224) 369 4230 
 
Title: Quality Engineer (2 Openings)
Duration: 2 Years
Location: Plymouth, MN
 
This is an On-site for now, and can be hybrid later (Monday and Friday)
Possibility of extension or conversion - Yes
 
Description:
 
Quality engineer experienced with internal or external auditing to internal QMS requirements; understands 21 CFR 820, ISO 13485, and CGMP Regulations.
 
There will be 2  different roles:
 
For 1st position:
  • The client is looking for a person who can support auditing, has an understanding of QMS, and global QMS requirements, helping SMEs with audit management, internal audits, execution and coordination level of audits, R&D for medical devices auditing, and reviewing QMS requirements. 
  • Industry experience - Medical device experience or pharma experience, or GMP is preferred.
  • Education: Degree- BS is nice to have.
For 2nd position:
  • Experience in lab control, who can also act as an SME related to auditing in GMP or the Pharma side, any experience related to regulations.
Work to be performed will be:
  • Understand Vantive QMS requirements at a detail level
  • Review Product and QMS documentation to evaluate compliance.
  • Maintain an internal audit schedule.
  • Assist in communicating internal audit agendas and scheduling
  • Participate in internal audits
  • Generate Internal Audit reports
  • Review and approve product and QMS work products as required
  • General Quality Engineer tasks as required.
    Interview process: 
    • Initial screening will be a phone call, followed by a possible onsite second round.

    About us:
    DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

    DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.