Quality Assurance Engineer

Category:
Information Technology
Industry:
Healthcare
Type:
Contract
Location:
Westborough, Massachusetts
Job ID:
#162767
Recruiter:
Seema Khan

Do you want to work for one of the largest “Healthcare” companies? They are currently looking for an “Quality Assurance Engineer” to support their facility in Westborough, MA.  If you’re interested and qualified, we urge you to apply!

Position Summary:

  • Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
  • Responsible for the review and approval of Engineering Change Orders (ECOs).
  • New Product introduction support. Review and approval of risk documentation, verification protocols and reports, and product specifications.
  • Coordinator of deviations and concessions for manufacturing.
  • Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
  • Initiates and owns non-conformance reports and CAPAs for manufacturing related issues.

Qualifications:

  • Bachelor's Degree or a minimum of 4 years work experience.
  • Minimum of 1-year experience working in a regulated industry or a master’s degree
  • Ability to communicate effectively in English (both written and oral). Strong writing skills is a must. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
  • Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
  • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

Looking for Meaningful Work? We can help.

If you're an Quality Assurance Engineer professional, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.

We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at recruit@ianmartin.com.

We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.

 

ewemi