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Sr. Manager, Quality

Company: Alphatec Spine
Location: Memphis
Posted on: August 8, 2022

Job Description:

DescriptionThis role will be Quality site lead responsible for management of Quality Control, Quality Engineering and Quality Assurance functions. This role will ensure freedom to operate, maintenance, and improvement of the Quality Management system for the distribution siteRequirementsESSENTIAL DUTIES AND RESPONSIBILITIES

  • Identify and execution mitigations to Local, Federal, and International medical device requirements. Support and prepare for regulatory audits.
  • Oversight of Operations procedures for QMS and Regulation compliance.
  • Manage budget for Quality functions within site.
  • Develop and implement International Distribution procedures in conjunction with Carlsbad support team.
  • Lead cross-functional teams in the execution of process changes
  • Recruit, train, and coordinate work of Quality staff.
  • Manage Non-Conformances, CAPAs, and Complaint Investigations in conjunction with Carlsbad support team as needed.
  • Identify, procure, install, and validate needed equipment.
  • Manage incoming Quality Control inspections for accuracy and efficiency.
  • QC lab maintenance, and continuous improvement initiatives
  • Manage site Calibration needs.
  • Manage Document Control tasks (scanning and uploading, record storage)
  • Manage any 3rd party resources.
  • Other duties as assigned.Supervisory ResponsibilitiesManages supervisors and coordinates the activities and responsibilities of entire Quality department.QualificationsThe requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    • Strong management and interpersonal skills needed.
    • QC, Calibration, NC, CAPA, SCAR, Quality Engineering management.
    • Operations compliance experience (recall administration, lot holds, etc.)
    • Equipment Validation (IQ/OQ/PQ) knowledge required.
    • FDA, ISO, QSR, knowledge required.
    • 3+ years supervisory experience required.
    • Advanced knowledge of Microsoft Office Suite and Outlook. EDUCATION And/or EXPERIENCEBachelor's degree; or equivalent experience required. 8+ years of experience in a medical device manufacturing environment in a Clinical, Quality or Regulatory Affairs role. 2 - 4 years of management experience.Benefits
      • Health Care Plan (Medical, Dental & Vision)
      • Retirement Plan (401k, IRA)
      • Life Insurance (Basic, Voluntary & AD&D)
      • Paid Time Off (Vacation, Sick & Public Holidays)
      • Family Leave (Maternity, Paternity)
      • Short Term & Long Term Disability
      • Free Food & Snacks
      • Stock Option Plan

Keywords: Alphatec Spine, Memphis , Sr. Manager, Quality, Executive , Memphis, Tennessee

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