Project Quality Engineer Ii Jobs in Ohio

Provide engineering technical knowledge to manage nonconforming product evaluation, execution, and containment to minimize impact to plant operations or customers.

2-6 years of experience based on education

Nonconforming procedure - Knowledge of QMS and government regulation requirements

Manage/schedule dimensional/formability activities during New Model/MP.

Create and maintain Stamping/Plastics dimensional/formability reporting and documentation for the department to manage overall part spec compliance.

Make, update and revise training material for dimensional data collection processes and conduct training to improve department skill level.

Effective time management, multitasking, and prioritization skills.

Collaborate with internal Thermo Fisher Teams and external contractors to define User Requirements and refine project scope.

Develops, reviews, & executes Change Control documentation and Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) protocols for Facility and Utility Changes

Understanding of quality and regulatory requirements for GMP environments and OSHA standards for facility and utility construction.

Experience leading capital projects – engineering and construction.

Excellent social skills to establish and maintain effective working relationships with cross-functional teams, contractors, suppliers, and clients.

Provides input to management on quality and compliance. Ensures corrective actions implemented are effective.

A minimum of two (2) years of working knowledge and experience in a cGMP/highly regulated manufacturing environment.

Ability to apply risk management philosophy to business processes, decisions and data.

Must have proven skills to perform tasks accurately.

Must have skills to perform tasks without continuous supervision but seeking input as needed.

Strong troubleshooting skills to assist with defining problems, collection of data, establishment of facts and drawing valid conclusions.

Combined technical and project management experience in the biotech industry

Strong leadership and management skills required

Experience with project management concepts, practices, and procedures.

Project Management Professional (PMP) Certification desired

Manages client and other project stakeholder relationships, communications, requirements and expectations, and interfaces directly with the client

Oversees all aspects of projects, sets deadlines, assigns responsibilities

Supports development, implementation and management of quality training and education programs

Oversees the design and implementation of a global Quality Management System

Establishes a common set of quality analytics to proactively monitor quality management systems including audits, documentation control, training

Oversees and manages compliance auditing and tracking, including the shared audit management process

Knowledgeable in current regulatory and/or quality certification(s) such as CQA, CBA, CQM, RAC, etc.

Demonstrated knowledge in quality processes and regulatory requirements such as ISO 9001, ISO 13485