Quality Manager - Houston, TX

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Job Description

Position Summary:

Quality Manager will manage quality assurance, control processes, and programs by developing, implementing, and administering quality standards and procedures assuring product quality, continual improvement, and customer satisfaction.

Quality Responsibilities:

  • Authoring/Creating all Quality System documentation (Reports, Protocols, Validations, Qualifications, Manuals, Procedures, Methods, Instructions, Analysis, etc)
  • Controlling the Quality Management System including the Quality Manual, Procedures (QSP), Specification, Test Methods, and Work Instructions.
  • Coordinating and documenting Management Reviews.
  • Working with department leaders to ensure their personnel understand and consistently follow QSPs, Work Instructions and Test Methods.
  • Working with department leaders to create, conduct, and document employee training, including new hires.
  • Working with department leaders to ensure all aspects of Product Development meet all applicable regulatory requirements.
  • Creating Design History Files and Technical Files.
  • Approving product development quality system documents.
  • Working with department leaders, complete CAPAs or NCRs, and Non-Conforming Records, ensuring consistency and compliance.
  • Managing supplier evaluation and control.
  • Maintaining contracts with OEMs and suppliers
  • Working with department leaders to determine the need for and frequency of any Process Validations / Revalidations.
  • Issuance of Work Instructions for production.
  • Managing controlled documents in order to maintain FDA Approval, ISO Certification, CE Certification, MDSAP and other country medical device certification
  • Obtaining and maintaining all product licenses and certification including FDA Registration, including 510(k), CE Mark and MDSAP records for new or existing products.
  • Maintaining registrations/licenses and supporting OBL registration/license activities.
  • Serving as Quality Management Representative.
  • Controlling GUDID records.
  • Managing internal, Notified Body audits. Facilitating FDA inspections.
  • Reviewing all marketing & advertising communication for regulatory compliance.
Required Qualifications:
  • Bachelor’s degree
  • At least 10 years’ experience in medical device industry managing a Quality System for FDA Class 2 devices, ISO 13485 Certification and CE Mark requirements.
  • At least 3 years management experience.
  • Highly proficient and accurate in writing and reviewing technical documents related to medical devices.
  • Flexible for new assignments.
  • Demonstrated ability as responsible for safeguarding confidential information.
 

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Details

Posted: Jun 18, 2018

Type: Full Time

Category: Quality Medical Devices Quality Manager Quality