The Quality Engineer position will be colloquially identified as MRB Coordinator. As MRB Coordinator, the employee will track and trend Quality Events, Cause Investigations, and CAPAs for the purpose of site communication and timely completion of actions. Will also execute such actions (QE Evaluations, Cause Investigations, Corrective or Preventative Actions) in addition to investigate customer complaints, carry out change controls, and ensure compliance with standards.
Duties/Responsibilities
- Perform all work in compliance with company quality procedures and standards. Performs other duties as assigned.
- Maintain compliance of Quality System elements applicable to the site/function (Complaints, Quality Events, Third Party Audits, Internal Audits, Change Control, Training); Manages inquiries related to Customer Complaints.
- Evaluate Quality Events for impact and trending.
- Investigate product failures for deviations, technical customer complaints, and CAPAs to identify, confirm and address root cause.
- Back up to the Complaint Coordinator position.
- Support the validation process from the Quality perspective.
- Maintain compliance to quality standards for all new and existing products.
Qualifications/experience
- Bachlors in the any of the following disciplines: Biology, Chemistry, or Engineering.
- Minimum 3 years of relevant industry GMP experience (preferably in Quality).
- One (1) year of engineering or investigative experience.
- Experience with GMP systems regulated by ISO or government agencies.
- Knowledge or experience with risk management.
- Advanced technical writing skills.
- Strong leadership and communication skills.
- Experience with Microsoft suite and TrackWise Digital.
- Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) desired.
