Validation​/CQV Engineer

This range is provided by Inte Pros. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$60.00/hr - $70.00/hr

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The purpose of the CQV Engineer is to complete assignments in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation. The successful candidate will assume responsibility for drafting qualification protocols, qualification reports and engineering study reports, along with data analysis and an intermediate level of experience in the use of statistics. This position will also support other projected related tasks such as developing strategies and protocols for performance testing, time study and value stream mapping, and development of equipment functional and user requirements.

DUTIES AND RESPONSIBILITIES

• Collaborate with Engineering and Quality on equipment / process changes, additions and installs for how to qualify equipment, processes and newly developed coatings
• Preparing and reviewing validation protocols, engineering study reports, results from trials and test work, parameter development and operational qualifications, including challenge tests to establish and demonstrate stable processes and capability. Collaborate with document control to approve and release into QMS.
• Perform basic to intermediate statistics for the analysis of data
• Update, where necessary, the Validation Master Plan with outcomes of executed qualifications / validations
• Lead and support process time studies, value stream and process mapping, and capacity analysis
• Support development of user, functional, and equipment requirement for new and existing equipment
• Work within the established company-wide quality documentation system and QMS, including key aspects such as executing and supporting test methods per procedure, collecting and documenting test results, writing test data reports and procedures
• Follow Quality Management System requirements in an ISO 13485 / GMP manufacturing environment
• Performs other related duties as assigned by management

QUALIFICATIONS

• Minimum of 7yrs experience in engineering or equivalent and an engineering bachelor’s degree
• Medical device and/or medical component experience is a must
• Can interpret schematics, engineering drawings, written and verbal instructions
• Understands the operation and functionality of process equipment; conducts tests and reports data in prescribed format
• Experience in planning, preparing and executing validations protocols and reports, writing and implementing procedures, development of processing parameters, executing and documenting trials, IQ/OQ/PQ, navigating quality management systems
• Strong computer and communication skills. Fluent in English, both written and spoken
• Self-motivated. Able to work effectively both within a team and independently
• Proven experience supporting complex problem solving using systematic and critical thinking skills

• Seniority level Associate

• Employment type
  
  Contract

• Industries Medical Equipment Manufacturing

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Medical insurance

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401(k)

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