Quality Systems Specialist

• Review and monitor deviations and nonconforming material reports using the eQMS and ensure all disposition activities and training are completed in a timely fashion.
• Ensure items and materials listed on lot history records are provided by approved vendors using accepted material. Including raw material certificates within shipping documents as required per MPI and SOP.
• Create parts within the eQMS and ensure that they are correctly linked to Suppliers, Customers, and related modules when this functionality is available.
• Assure that all quality system records including traceability records are scanned, stored, and retained as defined in SOPs Standard Operating Procedures (SOPs).
• Perform layered process and product audits and/ or Gemba walks at the direction of Quality management.
• Perform inspection, measuring, testing and data collection for critical milestone tasks. Assist Engineering, Manufacturing and Quality in support of equipment validation activities, including verification inspection/testing activities.
• Train and mentor Quality Inspectors and Technicians.
• Works semi-independently to perform operations under minimal supervision.
• Compliance to all applicable Standard Operating Procedures (SOPs) and adherence to CER gowning and personnel hygiene requirements. Ensure others in controlled environments always follow these requirements.
• Assist with Material Review Board (MRB) for nonconforming and suspect materials.
• Oversee Deviations for expiration and ensure relevant deviations are included with lot history records.
• Assist in maintaining an accurate equipment calibration and preventive maintenance program.

COMPETENCIES:

To perform this job successfully, and individual should demonstrate the following competencies:

• Interpersonal Skills – Provide clear input to engineering and operations staff on required actions.
• Oral and Written Communication – Listens and gets clarification. Writes clearly and informatively;
  Able to read and interpret written information.
• Teamwork – Balances team and individual responsibilities;
  Contributes to building a positive team spirit.
• Motivation and Planning/Organizing - Measures self against standard of excellence. Uses time efficiently.
• Professionalism – Approaches others in a tactful manner;
  Reacts well under pressure;
  Treats others with respect and consideration regardless of their status or position;
  Accepts responsibility for own actions;
  Follows through on commitments.
• Quality – Demonstrates accuracy and thoroughness;
  Looks for ways to ensure a culture of compliance;
  Applies feedback to improve performance;
  Monitors own work to ensure quality.
• Safety and Security – Observes all safety and security procedures;
  Reports potentially unsafe conditions;
  Uses equipment and materials properly.
• Adaptability – Adapts to changes in the work environment;
  Manages competing demands;
  Changes approach or method to best fit the situation;
  Able to deal with frequent changes, delays, or unexpected events.
• Attendance/Punctuality – Is consistently at work on time;
  Arrives at meetings and appointments on time.
• Dependability – Follows instructions, responds to management direction;
  Takes responsibility for own actions;
  Keeps commitments;
  Commits to long hours of work when necessary to reach goals;
  Completes tasks on time or notifies appropriate person with an alternate plan.
• Initiative – Asks for and offers help when needed.
• Innovation – Generates suggestions for improving work.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to…