Computerized System Quality Engineer

Manchester, NH

Full Time

Experienced

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 system, machine control, software, data collection and storage used at Merrimack Manufacturing in accordance with change management processes, 21CFR part 820 and part 11.

Conduct code reviews to verify scope of change and quality standards are maintained.
Knowledge of Change management processes, 21CFR part 820 and part 11, GAMP5, Project Lifecycle models
Ensure changes to production equipment software are properly documented prior to testing and prior to 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 associated with observed issues or control systems risks, development of corrective actions and implementation of changes.
Generate and formalize standardized methods for conducting routine work associated with computerized systems.
Conduct smoke testing during development lifecycle stage, document bugs, verify updates and releases software for formal change control.
Maintain frequent and regular contact with operations, engineering and quality departments to understand and ensure observed or perceived 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.
experience with PLC, Ethernet/IP, and remote I/O communications protocols
Understanding of JAVA, Python, SQL and/or Visual Basic.
Understanding and ability to use Excel, Word, Access, and all related computer software for machine design, programming, backup, and monitoring
Knowledge of GAMP5 and different Project Lifecycle models preferred.
Excellent interpersonal, verbal and written communication skills
Ability to manage multiple priorities daily

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