Quality Engineer (Must Have Complaint Investigation)

About the role

The QM Engineer I is responsible for gaining experience in the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems. Learning to apply the Quality Systems to ensure compliance as well as having the knowledge necessary to apply the appropriate statistical and analytical tools. Works with various enterprise systems/Corporate directives to support new and/or current product lines and processes.

Responsibilities

• Developing/implementing tasks associated with plant activities or projects of general complexity within planned schedules/timelines
• Supporting audits
• Participating on teams
• Ensures documentation compliance
• Processing CAPAs, change control, and deviation waivers
• Routine interaction with other functional areas such as Operations and other Quality groups
• Reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant

Requirements

• Knowledge/Skills: Complaint investigation is a must. Ability to identify Quality issues and recommend corrective actions that can lead to resolution of general or routine complexity. Accesses policies and procedures for guidance. Capable of using Microsoft programs and ability to learn other systems. Basic knowledge of statistical methods and quality tools, as well as statistical application software. Effective verbal and written communication skills. The ability to work in teams, independent of supervision, to obtain planned results. Must be self-motivated, organized, detail oriented and have ability to multi-task.

Qualifications

• Education: BS or BA in related field required. Typical degree in Biological Sciences, Chemistry, Engineering, Computer Science and/or Regulatory Affairs or other related field.

Skills

• Knowledge/Skills: Complaint investigation is a must.

Pay

TBD

Schedule

M - F 8am - 5pm