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    Global CAPA Engineer - Fort Washington, United States - Oliver Healthcare Packaging

    Oliver Healthcare Packaging
    Oliver Healthcare Packaging Fort Washington, United States

    Found in: Lensa US 4 C2 - 6 hours ago

    Default job background
    Description
    *Based out of East Coast Headquarters in Trevose, PA*

    *Preferred candidate able to commute daily to one of our sites located in Trevose, New Britain or Feastervill depending on the needs of the business*


    Global CAPA Engineer

    Position Summary

    The CAPA Engineer is responsible for maintaining the Corrective and Preventive Action (CAPA) system to improve the quality of our products and processes at all OHCP sites.


    Primary Responsibilities


    • Direct activities to investigate, correct, prevent and verify the effectiveness of all CAPAs.
    • Actively engage with process stakeholders to lead problem-solving activities and root cause analysis using industry standard methodologies, ie- flow chart, logic tree, fishbone, six sigma DMAIC model, A3, 5-Why, 8D, etc.
    • Collaborate with process stakeholders to identify CAPA action plans that focus on prevention and mistake-proofing.
    • Measure the effectiveness of CAPA action plans using objective data.
    • Manage the CAPA records throughout all stages of process through closure.
    • Evaluate priority of improvement opportunities based on resources available, impact on customers, impact on the business and cost.
    • Identify opportunities to share solutions across sites as preventive action.

    Basic Qualifications
    Education

    • Bachelor's degree, certification or equivalent in the Medical Packaging industry or Quality Assurance field.
    • Five years related experience and/or training, preferably in a regulated industry such as food, medical device or pharmaceuticals.

    Experience

    • Strong knowledge of GMP and ISO 9001 or 13485 requirements.
    • Stronganalytical skills, ability to analyze and interpret data using varioussoftware tools such as MS Office, MiniTab or related statistical software.
    • Strong knowledge of industry standardroot cause investigation tools.
    • Solidverbal and written communication skills.
    • Strongorganizational skills and the ability to effectively manage time andmultitask.
    • Abilityto write reports, business correspondence, and procedures.
    • Read, analyze,and interpret SOPs and Regulatory Standards.
    • Abilityto bring team members from multiple departments and with differentperspectives and goals to become effective CAPA investigation teammembers.
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