Quality Manager

Danaher   •  

Putnam, CT

5 - 7 years

Posted 239 days ago

This job is no longer available.

Job ID: PAL001699

Description

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



Qualifications

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