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Senior Quality Engineer

2 months ago

Milpitas, United States Galaxy Therapeutics Full time

ABOUT GALAXY THERAPEUTICS INC.

Galaxy Therapeutics is a private, US-based, clinical stage medical device company. We have a proprietary implant technology to treat brain aneurysms. Brain aneurysms occur in up to 6% of the population. Up to half of brain aneurysms require treatment. This is over a $1B Market Opportunity. We are addressing this opportunity with the Saccular Endovascular Aneurysm Lattice treatment system: SealTM. Galaxy is currently at an early clinical stage. We have successfully demonstrated proof of concept, and clinical safety with our Pre SEAL IT trial which enrolled 33 patients at multiple sites. Safety, efficacy and durability has been demonstrated in all patients. We are currently working with FDA to launch our Pre-Market approval SEAL-IT trial in US and internationally. Galaxy holds multiple patents in US, EU, China and other markets. Founded by four practicing neuro interventional physicians. Our core team is based in Milpitas, CA.


ABOUT THE ROLE

The Senior Quality Engineer will be responsible for ensuring applicable quality requirements are met for the development of new products and sustaining quality throughout the product development life cycle including sustaining support after commercialization.  


ROLE RESPONSIBILITIES

  • Compliance with US and International Regulatory Requirements.
  • Compliance with Galaxy Therapeutics Policies and Procedures.
  • Drive corrective actions in response to negative trends.
  • Routine daily production support.
  • Final Inspection Method determination including Sampling Plans, Acceptance criteria, equipment selection, and Test Method Validation.
  • Component Quality including Incoming Inspection, Criticality assessment, Sample Size Selection, Inspection Method determination and Validation, Inspection Equipment Selection, qualification, and validation.
  • Gage R&R Studies.
  • First Article Inspection requirements determination.
  • Establishing Statistical Process Control in production.
  • Support Process/Product Validations through Sample Size determination, Normality Testing and Data Analysis.
  • Create and/or revise quality documents to assure accuracy and compliance.
  • Interface with FDA, Notified Body and state auditors during inspections.
  • Perform investigations and corrective actions per the corrective and preventative action program.
  • Maintain DMR and DHR files.
  • Participate in complaint investigations.
  • Manage the material review board activities per control of non-conforming materials.
  • Participate in and support product development projects and teams.
  • Proactively communicate project status to management.
  • Review and provide input into testing methodologies, acceptance criteria and test plans. Work with project team to investigate and assess all failures that occur during product design verification and design validation.
  • Help validate products through concept, design, development and transfer to manufacturing operations and subsequent release into commerce. Work with team to ensure that customer requirements can be validated and design requirements can be verified. 
  • Establish trend analysis tools to report on operational performance, product quality and monitor the effectiveness of corrective actions related to deviations, internal audits, customer complaints, and supplier performance.


OTHER RESPONSIBILITIES:

  • Perform supplier quality audits as required.
  • Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or Quality Assurance
  • Maintain corporate confidentiality at all times.


QUALIFICATIONS AND SKILLS

  • B.S. in Mechanical or Biomedical Engineering, MS preferred
  • Minimum of 5 years of experience in medical device quality
  • Demonstrated understanding of 21 CFR 820, ISO 13485 and MRD 2017/745
  • ASQ Certified Quality Engineer preferred
  • Experience in print and specification review and change orders.
  • Must have excellent problem-solving skills, ability to diagnose issues, find and test solutions.
  • Must have good ability to communicate technical subject matter effectively, orally and in writing, to technical and non-technical audiences.
  • Experience with processes and process validation during qualification phases is preferred.
  • Ability to identify problems and communicate solutions in a constructive and positive manner in a fast-paced working environment.