Quality Engineer

Organization
Enzymatics - A QIAGEN Company
Job Location
Beverly, MA
Job Description

POSITION SUMMARY

The Quality Engineer will report to the Quality Assurance Manager. S/he represents Quality within cross-functional teams to coordinate documentation and ensure compliance for instrument IQ/OQ, assay Verification/Validation activities and Risk Management. Position responsibilities also include monitoring Engineering Change Controls and data trending to provide corrective action solutions that drive continuous improvement.

 

RESPONSIBILITIES

Job performance will involve a variety of activities including:

  • Work in collaboration with product development to ensure that the designs, procedures and outcome of the project are acceptable in quality.
  • Support the creation and the maintenance of Risk Management plans including dFMEAs, pFMEAs and Control Plans.
  • Write or review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams.
  • Conduct and support investigations of manufacturing nonconformities, recommend, develop and implement effective corrective actions.
  • Applies statistical methods for analyzing data to evaluate the current process and process changes and solve problems. 
  • Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics
  • Participates on audits conducted by regulatory agencies and/or customers.
  • Participates in supplier evaluation and selection assessments.
  • Maintains a working knowledge of industry standards. Knows and follows the ISO quality system guidelines. 
  • Performs external vendor audits to ensure ISO and/or FDA compliance.
  • Additional responsibilities may be assigned as needed.
Requirements

Experience

  • Between 4-6 years of overall QA experience in an ISO and/or FDA regulated environment, with at least 2 years in direct QE role.
  • Experience with ISO 13485 certification, (FDA 21CFR 820 and 21CFR Part 11 also desired).
  • Experience with Risk Management per ISO 14971:2012 desired.
  • Experience in a Good Manufacturing Practice (GMP) environment.
  • ASQ certified Quality Auditor and/or Quality Engineer - CQE, CRE, PE, CRA and/or Lean Six Sigma Certifications are highly desirable.


Key Attributes

  • Drive and Determination
  • Positive external and internal relationship management skills
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
  • Proven ability to thrive in a change oriented environment
  • Must be proficient in MS Office (Word, Excel, PowerPoint);


Education:   

  • Bachelor's degree preferably in a life science discipline, or equivalent experience.
  • ASQ CQE, CQM, or CQA preferred.
About Our Organization

QIAGEN is the leading global provider of Sample to Insight solutions to transform biological materials into valuable molecular insights.

QIAGEN sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective molecular testing workflows.

QIAGEN provides these workflows to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research).

As of June 30, 2015, QIAGEN employed approximately 4,400 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

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