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Quality Systems Specialist

Quality Systems Specialist

Astemo IndianaSunbury, Pennsylvania, USA
1 day ago
Job type
  • Full-time
Job description

Job Family : Quality Management

Job Description :

Position Name : Quality Senior Specialist - Auditing

Reports To : Manager I - Quality Systems

Job Tasks Objectives Prerequisites Etc.

Prerequisites

  • Ability to facilitate groups in root cause problem solving
  • Ability to maintain confidentiality of information
  • Ability to multi-task and handle large volumes of work in a fast-paced environment
  • Ability to travel occasionally with little notice and some international travel.
  • Ability to work flexible hours in support of 3-shift operations and video conferences with HQ in Japan.
  • ASQ certifications in Auditing preferred
  • Excellent communication skills with the ability to clearly and directly communicate both written and verbally.
  • Knowledge of AIAG Quality standards (i.e. DFMEA PFMEA PCP PPAP etc.)
  • Microsoft Office expertise in Excel Word PowerPoint and Project
  • Root Cause Problem Solving and Corrective Action (8D 5P 5 Why)
  • Strong analytical troubleshooting and decision-making
  • Strong follow-up skills

Responsibilities

  • 5S 3T compliance
  • Adhere to Safety Policy and practices.
  • Assist Associates with MQ1 Items
  • Assure Conformance to requirements for outside audits
  • Compile and Update Open / Past Due Audit CPR / Issue Reports
  • Conduct Audits as Schedules (Training Process Assurance Quality Systems)
  • Conduct Special Audits as required
  • Confirm Audit Countermeasures
  • Confirm Audit Findings
  • Confirm Audit Requirements
  • Coordinate Audits as scheduled (Training Process Assurance Layered Process Audits Quality Systems)
  • Develop and Manage Audit Schedules (Training Process Assurance Layered Process Audits Quality Systems)
  • Develop Checklist (Training Process Assurance Layered Process Audits Quality Systems)
  • Evaluate countermeasures proposed to correct negative trends
  • Follow all company policies and regulations per the associate handbook or other written standards that apply to his / her job assignment
  • Follow up and Analyze Audits (Training Process Assurance Layered Process Audits Quality Systems)
  • Lead special projects and other duties as required.
  • MQ1 Audit System Verification
  • New Hire Orientation
  • Participate in CM meeting for findings from Outside Audits
  • Participate in Outside Audits
  • Perform additional projects assigned by department head and support all shifts as required
  • Perform Product / Process Audits to verify products are manufactured and inspected in accordance with standards.
  • Post Open / Past Due Audit CPR / Issue Reports weekly
  • Prepare Associates for Outside Audits
  • Prepare documentation for Outside Audits
  • Reporting of Open / Past due Audit CPRs / Issues (Training Process Assurance Layered Process Audits Quality Systems)
  • Review completed audits for accuracy
  • Support departmental 6S activities
  • Update and Manage Auditor Training (Training Process Assurance Layered Process Audits)
  • Verify / Close Audit findings
  • Verify and Close Audits (Training Process Assurance Layered Process Audits Quality Systems)
  • Work cross-functionally across Operations R&D support departments and Corporate Quality to meet internal and customer quality requirements.
  • Enter Layered Process Assurance Audits
  • Review and approve Quality Documentation (PQCT Table II Manufacturing and Operator Checksheets)
  • Equal Opportunity Employer (EOE) Qualified applicants will receive consideration without regard to their race color religion sex sexual orientation gender identity disability protected veteran status and national origin.

    At Astemo were challenging the status quo with the power of diversity inclusion and collaboration. Our goal is to build an inclusive work environment that celebrates the differences of our employees. We want to ensure that every employee feels valued respected and empowered. We dont just accept differencewe celebrate it we support it and we thrive on it for the benefit of our employees our products and our community. Astemo is proud to be an equal opportunity employer.

    If you need a reasonable accommodation to apply for a job at Astemo please send the nature of the request and contact information to when applying for the position.

    Required Experience :

    IC

    Key Skills

    Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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