What are the responsibilities and job description for the Design Quality Engineer position at Actalent?
Description:
Design Quality engineer will be responsible for developing the design of experiment for various validations for new product development. Engineer will be responsible for reviewing product manufacturing and quality standards and ensure documentation and test validation meets FDA code and regulation as well as perform DOE, IQ/OP/PQ for new processes being developed.
Skills:
quality standards, design control, Project management, Quality control, Quality assurance, capa, iso 13485, quality management system, risk management, validation, iso 9001, quality management, quality engineering, medical device, design assurance, corrective action plans, engineering, quality system, design, pfmea, fda, gd&t, fmea, iso 14971, new product development, risk assessment
Top Skills Details:
quality standards,design control
Additional Skills & Qualifications:
Direction and oversight over product and process validations. Reviews & approves IQ/OQ/PQ validation protocols and reports. Reviews & approves documentation for FDA submissions Creates and revises Standard Operating Procedures (SOPs) and Work Instructions (WIs) as required Provides input into quality data with company MM processes to equipment and validations Oversight of calibration program at company MM. Performs other related duties as assigned 4-year degree plus 4 years work experience in a regulated industry, or 8 years of experience in regulated industry Experience and intermediate knowledge of MS Excel SAP experience preferred Prior experience working in FDA regulated environment including medical device
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $80,000 - $100,000
