Quality Systems Specialist I

Job Description

Title: Quality Systems Specialist I

Department: Quality

Reports to: Quality Systems Manager

Starting Hourly Rate: $21

Benefits: Full time associates are eligible for benefits the first of the month following 30 days of service.

• • Medical Insurance
    • HDHP, HSA Plan - Employer Contribution of $1,040/yr.
    • High/Low PPO
    • FSA
  • Dental Insurance
  • Vision Insurance
  • Employer Paid Basic Life Insurance
  • Supplemental Life Insurance
  • Employer Paid Short Term Disability
  • Long Term Disability
  • 401(k) 4% Employer Match
  • Paid Time Off (accrued hours, 120/yr.)
  • 9 Paid Holidays
  • EAP Program
  • Fitness Room

Summary: Quality position primarily focused on achieving compliance with Quality System requirements.

Works under the direction of the Quality System Manager to implement Quality System requirements for assigned Quality System processes including, but not limited to, Change Control, Post Market Quality, Handling Nonconforming Material, CAR/CAPA, Equipment/Gage Calibration &Preventive Maintenance, Environmental Controls, Record Management, Internal and 3rd Party Audits, Graphics/Labeling, Job Closing and Production Support.

Duties/Responsibilities include but are not limited to:

• Follows all Quality procedures and policies ensuring that Quality System requirements are achieved in an ethical manner.
• Maintains current knowledge of applicable regulations and standards associated with the Quality System.
• Maintains current understanding and compliance with applicable process procedures and company policies.
• Meets commitments on time, in full, and with accuracy and attention to detail.

• • Supports Quality Team and Management relative to Document Control and Change Management:
    • Process document create/revise to implement Quality System changes
    • Utilize document control software to manage controlled procedures (active and archived)
    • Ensures that training is appropriately updated and maintained in software system associated with Quality System Training and documentation changes
  • Maintains records and external documents per applicable procedures
    • Maintains external documents associated with product including supplier documentation
    • Maintains external documents associated with Quality System
    • Maintains Quality System records in accordance with retention policies.

Nonconforming Material Requirements:

• • Reviews and supports evaluation of all reported material nonconformances (prior to material release) ensuring appropriate segregation, disposition and corrective actions are implemented
  • Communicating both internally and with customers as needed, regarding material issues and dispositions
  • Utilizes ERP system to document, track and trend nonconformance information
  • Supports the production teams in ensuring timely resolution of nonconforming material
  • Ensures that disposition actions are completed and verified in timely manner (according to procedure)
  • Works closely with Engineering groups for technical support on evaluations and disposition actions.

Post Market Requirements:

• • Reviews and investigates all customer returns, complaints, and customer requests for support relative to product conformance ensuring appropriate disposition and corrective actions are implemented in timely manner (according to procedure)
  • Utilizes Epicor to document, track, and trend post market information
  • Communicates both internally and with the customers as needed to resolve product issues
  • Supports customer needs relative to vigilance reporting, product failure investigation, and regulatory inquiries regarding product
  • Works closely with Engineering groups for technical support on investigations and corrections

CAR/CAPA Requirements:

• • Reviews and investigates requested or assigned CARs/CAPAs
  • Coordinates investigations for root cause and development of appropriate corrective actions
  • Ensures that documentation (paper and Epicor) is accurate, consistent, and complete
  • Ensuring that procedural timeframes are met to ensure timeliness of the process
  • Utilizes Epicor to track and trend corrective action implementation and closure
  • Communicates both internally and with customers as needed regarding CAR/CAPA status and effectivity

Notes: This Job Description is intended to be an accurate reflection of the current job as of the document effective date. This job description is not intended to be an exhaustive list of all required skills, duties, responsibilities, or qualifications associated with the positions described herein. The company reserves the right to revise or amend the qualifications, functions and duties of the jobs or to require that additional or different tasks be performed if business circumstances change. Employees are held accountable for performing the duties of their position, as evaluated by documented scorecards and performance management reviews based upon company specified metrics and goals documented in the scorecard for which the employee is made aware and maintains.

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Salary : $1,040