Quality Manager

Company: ABEC
Location: Bloomsbury
Posted on: September 13, 2023

Job Description:

Position Summary: The Quality Manager leads the Global DC Quality team with implementation of company-wide operations procedures and process to support the overall Quality Assurance plan. This role supports Quality improvement throughout the shop floor and within the team concept. This role will participate as a cross functional team member. Responsibilities:

• Oversee all Quality staff
• Coach, develop and provide guidance to Quality staff.
• Ensure cross-training of all Quality staff, so that all internal and external (service/installation) needs can be met.
• Drive efficiency and productivity within the team.
• Review and evaluate site Quality staff performance
• Maintain and ensure compliance to ABEC Standard Operating Procedures (SOPs).
• Support and maintain ABEC quality procedures, practices and guidelines, including best industry practices such as Good Documentation Practices (GDP).
• Participate in process, internal and mock customer audits, as directed.
• Perform vendor qualification or re-qualification audits, as directed.
• Coordinate and support Customer audits of the ABEC site, as directed.
• Coordinate assigned CAPA activities (Root cause analysis, short- & long-term corrective and preventive actions) Coordinate assigned Continuous Improvement initiatives, driving both cost and process improvements.
• Coordinate Quality System Change Management assignments as directed
• Coordinate calibration activities at all ABEC DC facilities
• Report to the Global Director of Quality on the status and metrics of the quality program for required sites.
• MRB Process signer, and trend analysis
• Maintain documents in ABEC archives
• Support and maintain ABEC Key Initiatives and Core Values.
• Execute other tasks as assigned
• Ability to travel when require Qualifications: Required
  • Bachelor's Degree in an Engineering discipline or related Life Sciences field
  • Minimum 5 years post graduate work in a Quality or Validation field, including leadership experience in a manufacturing environment
  • Experience with cGMP, ISO 9000 or equivalent.
  • Must be able to travel domestically and internationally. Preferred
    • Ability to lead, supervise and coach a team of 20 or more quality staff.
    • Experience with reporting of KPI metrics of the quality program for specific site such as DPM
    • ASQ CQE, ASQ, CQM and Six Sigma would be a plus PI229380652

Keywords: ABEC, Bethlehem , Quality Manager, Executive , Bloomsbury, Pennsylvania