Engineer, Quality

Responsibilities

• Maintenance of the approved supplier list including material, service, and supplier qualification, performance, and discontinuation.
• Aids Materials Management, Procurement, and QA functions with material and supplier approval/rejections and supplier issue resolution of purchased materials.
• Aids site Manufacturing operations and Quality Assurance with supplier related event resolution, communication, and supplier-related corrective actions.
• Maintains an effective liaison and cooperative relationship with internal, global, and cross-functional departments.
• Implements and maintains the effectiveness of the Quality System.
• Supports the achievement of quality goals, ensures practices and procedures comply with company policies and applicable regulations.
• Ensures thorough investigation of site supplier events, accurate documentation, and inclusion in the plant CAPA system.
• Performs product impact analyses for site supplier events and places material/product on QA hold where appropriate.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.
• Participates in internal and external audits as the subject matter expert for site supplier quality assurance.
• Develops and implements statistical quality programs, ensures all acceptance sampling meets expected product quality confidence levels for manufactured and purchased materials.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience.
• 2+ years of overall experience in Manufacturing, Quality or Engineering.
• Good verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Good negotiation skills.
• Knowledge of quality / compliance management as well as regulations and standards affecting Incoming Materials, API, Bulk Drug or Finished goods manufacturing.

Preferred Qualifications

• Knowledge of quality systems (TrackWise, Veeva OneVault/OneTrack, SAP Enterprise).
• Processing software (excel, PowerPoint, word, SharePoint, etc.).