Quality Engineer

Description

The Quality Engineer will execute such actions (QE Evaluations, Cause Investigations, Corrective or Preventative Actions, Corrections, QMS Tasks) in addition to investigate customer complaints, initiate and complete change controls, and ensure compliance with site, regional, and global standards.

The QE will perform one (at minimum) site process or operational audit. Supports external audits from regulatory agencies and customers as needed. Drives continuous improvement and manages projects as appropriate.

Primary Duties:

• 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);
• Investigate product failures for deviations, technical customer complaints, and CAPAs to identify, confirm and address root cause.
• Complete Quality requirements for batch record release.
• Serve as back up to the QA Supplier Management Lead.
• Support the validation process from the Quality perspective.
• Maintain compliance to quality standards for all new and existing products.

*The position does not have employees to supervise or an operating budget.

Qualifications:

• Bachelor's degree required. Preferably, in a field of science or technology

Experience:

• 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.
  

Knowledge, Skills, and Abilities:

• High end critical thinking, technical knowledge of microbiology and/or GLP, and time management.
• Computer skills required, including Microsoft Word, Excel, PowerPoint, and Outlook. Electronic Quality Systems such as LIMS, Blue Mountain Regulatory Asset Management, and SAP experience preferred.
• Excellent interpersonal skills and ability to work with all levels of an organization
• Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
• Must be able to work effectively in a team based environment.
• Detailed oriented.
• Strong analytical and problem-solving skills. Ability to translate written instructions, work orders and specifications.