Payroll Analyst

Role : Quality Engineer II

Location: Onsite - 111 Locke Dr Marlborough Massachusetts 01752

Duration: 6+ months contract

Essential Duties and Responsibilities:

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 results