iSixSigma

Manager, Quality Operations

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West Pharmaceutical Services
Published
November 12, 2020
Location
Scottsdale, AZ
Job Type

Description

Job Summary:

In this role, you will assure compliance of the plant processes and product to established standards, specifications, and procedures. As the ISO management representative at the plant level, ensure quality system is implemented and its integrity maintained.

Essential Duties and Responsibilities:

  • Directs and manages quality auditors, metrology personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible
  • Ensures timely resolution to audit findings and customer complaints
  • Utilize PMI strategies and techniques to manage scope, time, and budget
  • Maintain clear communication paths with stakeholders
  • Conduct routine resource reviews with project teams and management
  • Manage and maintain an effective Quality Assurance program for the plant in alignment with site and enterprise procedures and capable of maintaining ISO 13485 certification status
  • Review operating procedures to ensure compliance with all related procedures, instructions and the quality manual
  • Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports
  • Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations
  • Manage quality staff at site to assure knowledge and execution of site Quality System
  • Drive continuous quality improvement projects at plant based on site data and customer expectations
  • Drive compliance to global harmonization initiatives
  • Assure proper use of change management associated with validated processes used by site
  • Adjust in process/final sampling plans & related accept/reject criteria to ensure compliance to specification
  • Other duties as assigned

Basic Qualifications:

  • Bachelor’s degree in Science or Engineering, or commensurate experience
  • 10 years of experience with a minimum six (6) years in Quality Assurance / Quality Control
  • Minimum four (4) years managing others

Preferred Knowledge, Skills and Abilities:

    • Experience with sterilization requirements and classified environments for production
    • Experience with Customer interface and meeting customer expectations
    • Working familiarity with Project Management Tools and Quality Risk Management
    • Experience with microbiology and particulate lab testing
    • Working knowledge of Medical Device requirements
    • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
    • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
    • Able to comply with the company’s safety policy at all times
    • Able to comply with the company’s quality policy at all times

Travel Requirements:

  • Must be able to travel up to 10% of the time

Physical & Mental Requirements:

  • Work in a manufacturing environment, subject to heat and cold as well as loud noise
  • Work in an office environment. At times must sit for extended periods of time
  • Ability to effectively communicate and comprehend complex ideas and concepts
  • Use written and oral communication skills
  • Read and interpret data, information and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems
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