QA Engineer

Quality EngineerOpen contract JOB DESCRIPTIONEssential Duties and Responsibilities: We are seeking an experienced Quality Engineer II that will actively participate in the ISO 9001:2015 Quality Management System. This role is responsible for providing Quality Engineering support for new product development, manufacturing transfer activities and supporting manufacturing for commercial products. Responsibilities: • Must be familiar with Validation Principles and Concepts, Design Controls Processes in accordance with regulatory requirements (e.g., Quality ISO standards, ASME BPE, CE, BPOG, REACH, etc.).·   Supports the New Product Introduction (NPI) team with deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. Work with multi-functional product development teams to help verify new product development deliverables and compile product Design History Files to support product release.·   Experience in areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. Product line support will focus on hardware devices and associated consumables used for biotech products.• Supports the comprehensive completion of risk management (FMEA), Design and Process Verification activities for products and processes.• Assists in the development and validation of appropriate test methods for product and process performance.• Review of Equipment IOPQ’s in support of commercial operations.• Strong organization skills with the ability to effectively muti-talk and prioritize• Self-motivated with sound judgment and problem-solving skills.• Assists with customer complaint investigations when required• Effective in executing change controls and running change control review board meetings.• Review and approval of nonconformances, deviations, failure investigations and corrective action plans prior to implementation when required.• Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal resultsEducation and/or Work Experience Requirements: Qualifications/Skills: • BA/BS degree (in a Biological Science, Engineering, or Physical Science required).• Must have prior experience in New Product Development Quality Engineering.• Experience with biotech hardware and consumable products and associated manufacturing processes.• Basic understanding of cell culture and filtration and chromatography operations in a bioprocess setting is required for this position.• Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred.• Minimum of 3-5 years’ experience as a Quality Engineer in an ISO 9001 Quality Management System or equivalent.• Internal Auditing.

Salary : $48 - $52