Manufacturing Quality Engineer

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Manufacturing Quality Engineer

Durham, NC

October 2021

HemoSonics, LLCis seeking Quality Engineer who will be responsible for reviewing Device History Records (batch records), incoming inspection testing, material specification and drawings to ensure accuracy in data to enable parts released for production and products released for sale.

Key Attributes of the Successful Candidate:

  • 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.
  • Ability to write and review SOPs, Forms, Work Instructions and review project team documentation.
  • Ability to demonstrate working knowledge of current and applicable GMP regulations e.g.: ISO13485:2016 / 21 CFR Part 820.
  • Knowledge of validation, statistical process controls, and regulatory compliance.
  • Demonstrated statistical analysis skills.
  • Strong computer/Microsoft Office skills.

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.
  • Utilize statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities, and develop statistically sound tolerance limits.
  • 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.
  • Review of equipment records (refrigerator, freezer, incubator)
  • Perform product and process FEMA and write risk reports.
  • 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 contributes to the non-conformance reporting system, driving timely disposition and closure.
  • Assist with performing root-cause investigations to establish/implement corrective action plans.
  • Lead and/or participate in MRB meetings. Identify non-conformance trends and develop and administer technical investigation and CAPA programs to resolve recurring quality problems.
  • 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

  • Assist or perform supplier quality audits to assist Manufacturing Engineering to address supplier quality issues.
  • Ensure Quality Management System and project documentation are maintained to ensure retrieval for audits.
  • Provide direction on GMP guidance and educate personnel on best practices.

Post-Market Surveillance

  • Support the Complaint Handling Unit by investigating, determining root cause and ultimate resolution of product failures. Work closely with RA/QA, Engineering, Operations, Clinical and other functional areas to evaluate actual potential of product failures and update risk management files as needed.
  • Contribute to product safety, product quality, and customer satisfaction related decisions (both databased and risk-assessment-based decisions).
  • Lead and/or support internal and external supplier audits and inspections.
  • Monitor and advise on how the product quality performance and publish data/reports regarding the effectiveness of the Quality Management System in achieving the product performance goals.

Education and Experience Required:

  • Minimum 3 – 5 years’ experience as a Quality Engineer 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 participating in internal and external audits (e.g., FDA, Notified Body, Supplier).
  • Experience with batch record review (DHR), incoming inspections, CAPA, non-conforming product investigations, deviations, change control, training and document control, complaint investigation, field action processes and risk management.
  • Certified Quality Engineer and/or Certified Quality Auditor preferred.
  • Knowledge of ISO 13485:2016 and 21 CRF Part 820 desired.

The position is based at our facility in Durham, NC and may involve travel to our HemoSonics facility in Virginia and to supplier sites as needed. HemoSonics requires employees to be fully vaccinated against COVID-19 or meet the requirements for a medical or religious exemption.

To apply, please email your cover letter, resume and salary requirements to:

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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