Job Title: Quality Systems Engineer (Computer Systems Validation)
Location: Milwaukee, WI (opportunity for remote)
Experience Level: 4-6 years
Position Summary: Responsible for executing computer systems validation for a Fortune 500 Medical Device company. Must be familiar with applicable regulatory and Quality Management System requirements.
Essential Duties and Responsibilities:
1. Execute computer systems validation in accordance with applicable regulations (GAMP5 and 21 CFR part 11.)
2. Support configuration changes to validated computer systems (SAP, Quality Management System, Equipment software etc.).
3. Address and resolve technical issues that impact validated systems.
4. Assist in development, validation and training on SAP and internal applications and other Quality Management System processes.
5. Support risk assessment process for all proposed changes to validated software and operating environments.
6. Work with process owners to fully utilize validated software capabilities to enhance their processes.
7. Learn, coordinate, and analyze databases associated with oversight of the Quality System and its reporting process.
8. Support and perform internal and external audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow up and recommendations.
9. Provide backup in reviewing and approving internal operating procedures.
10. Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related audits and inspections as required.
11. Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to ISO quality systems and federal regulations.
12. Provide support within the Quality department and to other internal departments as directed by Quality Assurance Management.
13. Must be comfortable working with customers, patients, regulatory bodies, vendors, etc.
Education and/or Experience (years):
- Minimum 4 years Computer Systems Validation in Quality Assurance and/or other regulated industry or similar experience.
- BS in a Physical Science or Engineering, or equivalent experience.
- ASQ Certification as a Quality Engineer or equivalent desirable.
Knowledge, Skills and Abilities:
Strong organizational, statistical, analytical and problem-solving skills. Knowledge of the corrective action process: failure analysis, problem identification and solution development and implementation. Experienced in utilizing Quality System Management Software. Understanding of ISO 9000/13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. Preferred experience in performing internal and/or supplier audits and training of personnel. Experience in Six Sigma methodology a plus.
Physical Demands: Some clean room work may be required. Lifting of light (less than 15 pounds) objects.
SQA Services is a leading Supply Chain and Quality Assurance consulting firm specializing in the management of Supplier Audit, Quality Engineering, and Inspection programs in the Aerospace/Defense, Medical Device, Automotive, and Pharmaceutical manufacturing industries. Clients leverage our network of quality professionals in more than 50 countries as an extension of their own supplier quality teams.
Role: Quality Engineer - Computer Systems Validation
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