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Senior Quality Assurance Manager

Company: Apple & Associates
Location: Buffalo
Posted on: August 8, 2022

Job Description:

Senior Site Manager, Quality AssuranceOur client, an Expanding and Successful Medical Device Manufacturer with about 270 FTE's, growing to 300 near Buffalo, NY has an opening for an Experienced Site Quality Manager (Senior level). GROWTH SITE: Being a growth site we are looking for individuals that are looking for development and future growth opportunities. In this role you will be contributing toward driving the quality system leadership for the entire facility. Ensuring the promotion of awareness of regulatory and customer requirement through the organization.
Leadership: This Senior Manager will manage a team of about 10 direct reports (Quality Supervisor, Quality Engineers and Technicians), with responsibility for all QS compliance, all product quality, communication with all customers (about 7-10 major ones) and oversight of all audits.
Senior Quality Manager SKILLS/COMPETENCIES:

  • Responsible for compliance to 21 CFR 820, ISO 13485, Quality policies
  • Acts as Site management representative and facility liaison to the metals division and is responsible for managing the Quality System
  • Ensures establishment and maintenance of site regulatory registrations
  • Provides oversight and ensure compliance for the site QMS: Internal audits, Training, Document Control, Supplier Quality Management, CAPA, NCR's and Calibration Systems
  • Final authority to reject or accept product(s)
  • Responsible for creating and delegating new associate training into the quality system as well as annual training for all existing associates
  • Management of Document Control to maintain Quality System Documentation, Device Master Record, Request for Change, and External Standards
  • Management of Gage Calibration system
  • Support implementation and continuous improvement of processes through SOP's, CAPA, supplier auditing and Management Reviews
  • Administer effective internal audits of the Quality System
  • Maintain customer complaint log, documenting returns and corrective actions to returns
  • Lead the Quality Department with associates who are trained to perform their assignments in a professional and timely manner
  • Reduce variation in gaging processes by implementing and monitoring most recent technologies in gaging
  • Automate inspection methods where possible to reduce manual inspections
  • Maintain corrective action system and review effectiveness and implementation of corrective actions
    Senior Quality Manager Qualifications:
    • Bachelor's degree required with preference in Technical field such as Industrial or Manufacturing Engineering
    • 5+ years of leading a team
    • Experience with ISO and FDA Regulations and Audits oversight or similar Regulated Industry Audits and Requirements.
    • Skilled in the use of statistics and root cause analysis or continuous improvement tools
    • Experience with machining, mills, lathes or similar metal processing environments
    • Excellent communications and organizational skills
    • Able to manage multiple priorities with many time constraints
    • Excellent computer skills
      New employees are eligible for the following benefits effective date of hire!
      • Medical, dental, and vision benefits
      • Company-paid life insurance and disability benefits
      • Generous Paid time off and 10 paid Holidays
      • 401k Plan with Company Match
      • Tuition Reimbursement

Keywords: Apple & Associates, Buffalo , Senior Quality Assurance Manager, Executive , Buffalo, New York

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