Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing start-up manufacturing company that will play a crucial part in bringing innovative and life-changing products to life.
Merrimack Manufacturing has an exciting position for a Computerized System Quality Engineer.
How you will make an impact:
As a member of the Quality team, the Computerized System Quality Engineer will provide oversight for enterprise systems, machine control, software, data collection, and storage used at Merrimack Manufacturing in accordance with change management processes, 21 CFR Part 820, and Part 11.
* Conduct code reviews to verify scope of change and quality standards are maintained.
* Knowledge of change management processes, 21 CFR Part 820 and Part 11, GAMP5, and project lifecycle models.
* Ensure changes to production equipment software are properly documented prior to testing and before returning to service.
* Generate and maintain engineering specification documentation and validation documentation in partnership with the Engineering organization.
* Execute testing procedures to ensure that software meets established criteria. Write deviation and non-conformance reports as observed.
* Support root-cause investigations related to observed issues or control system risks, develop corrective actions, and implement changes.
* Generate and formalize standardized methods for conducting routine work associated with computerized systems.
* Conduct smoke testing during development lifecycle stages, document bugs, verify updates, and release software for formal change control.
* Maintain frequent and regular contact with operations, engineering, and quality departments to understand and ensure issues with equipment, systems, and reporting are documented, contained, and corrected.
To be successful in this role, you will need the following skills and experience:
* Bachelor's Degree in Electrical Engineering, Computer Engineering, Controls Engineering, or equivalent; Associates with equivalent experience also acceptable.
* Experience with PLC, Ethernet/IP, and remote I/O communication protocols.
* Understanding of JAVA, Python, SQL, and/or Visual Basic.
* Proficiency with Excel, Word, Access, and related software for machine design, programming, backup, and monitoring.
* Knowledge of GAMP5 and different project lifecycle models.
* Excellent interpersonal, verbal, and written communication skills.
* Ability to manage multiple priorities daily.
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