PLS Reedsville Mfg Slry- Coordinator, Quality Compliance

Jadex•Reedsville, PA

3d•Onsite

About The Position

Alltrista is a high-volume manufacturer with primarily manufacturing of medical components, medical packaging and medical devices. Alltrista also manufactures consumer goods. The primary responsibility of this position is handling complaints and nonconformances internally and externally. Secondary responsibilities include managing supplier quality, the internal audit program and aiding in training. Utilize your experience in root cause analysis and quality systems to determine corrections that aid in the effectiveness of our Quality Management System. Expand your knowledge with our cross training where this position has cross training with both Calibration as well as Document Control.

Requirements

Root Cause Analysis Training
Excellent computer capabilities, including MS Office.
Interpersonal skills required to communicate in accurate manner to individuals and to the team to develop a cohesive group.
The ability to work with and maintain information of a highly confidential and sensitive nature.
Excellent communication skills, both written and verbal.
Demonstrated ability to display diplomacy in day-to-day interactions with the commitment to task with awareness of urgency.
The ability to work independently and work as a value add to plant team efforts.
Associate degree or at least 5 years of equivalent experience in Quality and Customer Relations

Nice To Haves

Lean Six Sigma Green or Black Belt
Injection Molding Background
Experience in a regulated facility (ISO 13485 preferred or ISO 9001)

Responsibilities

Manages the Corrective Action process by receiving, documenting, and corresponding with customers, suppliers and the manufacturing team.
Facilitate Corrective Action meetings/teams to resolve customer, supplier and internal corrective actions.
Functions as the ISO Coordinator and oversees the internal and external audit programs.
Issues documentation for completion of internal audits and reviews and approves audit reports.
Issues corrective actions with regards to internal/external audit findings and reports those finding to management and/or customers and/or 3rd party auditors.
Functions as the Deputy Management Representative when the Quality Manager is unavailable during audits, customer communications and Management Review.
Responsible for reporting and investigating any material on hold (DMR) to make sure materials are placed back in inventory or destroyed in a timely manner.
Manages the supplier program to ensure new and existing suppliers have submitted all necessary documentation as it pertains to the Quality System.
Functions as the back-up for the calibration program, including scheduling to ensure all gages maintain current calibration.
Coordinates training for quality alerts.
Functions as the back-up Document Control Administrator.
Ensures onboarding training effectiveness by communicating with new hires and ensuring appropriate understanding of the material has been obtained.
Completes random production floor audits to ensure compliance with applicable regulatory requirements and internal procedures, including good documentation practices.
Conducts verification of effectiveness in corrective actions as a 3rd party verification source.
Manages the Pest Control program as it pertains to scheduling, reviewing and responding to any open pest control issues in the facility.
Supports the QMS by adhering to the system requirements.
Understands and follows plant safety rules.
Helps to identify and eliminate any safety hazard or concern.
Assists in monitoring of quality of work output.
Maintains compliance with company policy and procedures.
Maintains a neat and orderly working area.
Responsible for reporting any problems or concerns to direct Supervisor.
Maintains good working relations with all other employees.
Strives to have no conflicts with other employees.
Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work.
Other duties as assigned.