Associate Quality Engineer

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Associate Quality Engineer (Manufacturing)

September 2020

HemoSonics, LLC is seeking an Associate Quality Engineer who will be responsible for reviewing manufacturing documentation including device history records (batch records), incoming inspection testing, material specification and drawings to ensure accuracy in data in order to enable the release of parts for production and the release of products for sale.

Key Attributes of the Successful Candidate:

  • Ability to demonstrate working knowledge of current and applicable GMP regulations e.g.: ISO13485:2016 / 21 CFR Part 820
  • Must have a “hands-on” approach and work effectively on cross-functional teams to establish and maintain appropriate processes pertaining to Quality.
  • Strong organizational and time management skills.
  • Excellent written and oral communication skills.
  • Ability to formulate appropriate responses to common Quality inquiries from staff or complaints from customers and regulatory agencies.
  • Ability to review, analyze, summarize, and interpret data for Management Reviews; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations.
  • Strong computer/Microsoft Office skills.
  • ERP and/or eQuality System experience a plus.
  • Knowledge of validation, statistical process controls, and regulatory compliance a plus.
  • Demonstrated statistical analysis skills a plus.

Key Responsibilities:

Product Acceptance & Investigations

  • Reviews and approves quality records for component and finished medical device release.
  • Timely review of incoming inspection records to ensure the quality of assigned components for release to production.
  • Timely review of Device History records to ensure the quality of assigned products for review for sale.
  • Supports maintenance of the Device History files, training records, and other quality system documents.
  • Track and report quality metrics for HemoSonics Management Reviews.
  • Actively contributes to the Deviation process, ensuring deviations are documented, followed, and closed in timely manner.
  • Actively contribute to the Rework process, ensuring reworks are documented, followed, and closed in a timely manner.
  • Writing and updating procedures as required to ensure the Quality System is compliant with ISO standards, FDA regulations and adherent to HIPAA

Product Development & Operations

  • Ensure Quality Management System and project documentation are maintained to ensure retrieval for audits.
  • Perform supplier quality audits to assist Manufacturing Engineering to address supplier quality issues.

Post-Market Surveillance

  • Support the Complaint Handling Unit by working closely with RA/QA, Engineering, Operations, Clinical and other functional areas to evaluate potential of product failures.
  • Contribute to product safety, product quality, and customer satisfaction related decisions (both databased and risk-assessment-based decisions).
  • Support internal and external supplier audits and inspections.

Education and Experience Required:

  • Minimum 0-2 years’ experience as a Quality associate/analyst in the diagnostics or medical device industry and BA/BS degree in science, engineering, or related technical field; or equivalent combination of skills and experience.
  • Experience with batch record review (DHR) and incoming inspections, CAPA, non-conforming product investigations, deviations, change control, training and document control, complaint investigation, field action processes and risk management.
  • Knowledge of ISO 13485:2016 and 21 CRF Part 820 desired.

The position is based in Durham, NC.

To apply, please email your cover letter, resume and salary requirements to: careers@hemosonics.com.

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

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