Quality Manager

Danaher   •  

Putnam, CT

5 - 7 years

Posted 239 days ago

This job is no longer available.

Job ID: PAL001699


Position Objective:

  • Planning, developing, and implementing ISO and cGMP compliance elements to enhance the Quality Management System
  • Project management to execute implementation plans, and drive quality objectives and goals.
  • Customer Audits and resolving customer complaints.

Essential Job Functions:

  • Manage customer complaints, nonconforming product, root cause investigation, corrective/preventive actions, audits, document control, and training daily

  • Assist with investigation of internal and external non-conforming product, materials, and components daily

  • Oversee the internal audit function to ensure ongoing compliance to the Quality Management System monthly

  • Perform necessary functions to verify corrective action effectiveness on manufacturing processes and support functions monthly

  • Develop and deliver quality training for manufacturing and support function personnel based on working knowledge of ISO, CFRs, and SOPs quarterly

  • Review/approve change control activities, non-conformances, customer complaint investigations daily

  • Manage external customer assessments from scheduling to audit close outs monthly

  • Responsible for measurement and analysis of Quality System trends monthly

  • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws

  • Perform other duties as assigned


Minimum Qualifications:

    • Bachelor’s degree in Science in Engineering, Biology (or science related), or Math


    • 5-7years’ experience in cGMP or ISO quality system manufacturing environment


  • 2-4years’ supervisory experience (preferred)


Position Competencies:

    • Uses and interprets statistical data for making business decisions


    • Ability to explain, describe, or share information clearly; Organizes information in a framework others can understand.


    • Expert ability to produce effective, concise written communications about technical subjects including engineering studies, qualification protocols, and technical reports. Reviews written material and recommends revisions.


    • Ability to work on multiple projects, managing a broad range of tasks and prioritizing activities


    • Strong team-building skills; Acts to promote commitment to a team task or goal


    • Ability to influence peers and managers to ensure that objectives are met on time


    • Performs on-the-job training using tools, equipment, and materials trainees will use


    • Demonstrated ability to effectively manage multiple moderately complex projects simultaneously.


    • Must demonstrate and project integrity to employees and customers and uphold the company’s highest ethical standards


    • Effective interpersonal skills at any level within the organization


    • Lead and offer opinions and direction to colleagues


  • Ability to interact effectively with internal and external customers in order to accomplish goals

Other Requirements:

    • Knowledge in Regulatory, Compliance Systems and Standards


    • Knowledge of ISO, FDA, cGMP’s, and CFR requirements


    • Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma.


    • Knowledge of Kepner Tregoe, SPC, and quality statistical methods and tools (preferred)


    • Experience in Kaizen events


    • Understanding and experience in the application of FMECA and DOE


    • Proficient computer skills in handling spreadsheets, presentations, and new systems


    • Ability to manage budgets


    • Applicable safety trainings such as: RCRA, DOT, etc.


  • Minimal bending, lifting, and pushing