Software Quality Engineer I

Terumo•Elkton, MD

4d•$68,000 - $90,000

About The Position

Software Quality Engineer I is a dual-purpose role that supports new deployments, sustaining, and/or optimization of the Manufacturing Execution System (MES) and the validation / sustainment of software that supports the quality system, manufacturing, distribution, and other GXP-related functions. This includes creating validation plans, reviewing and approval of software changes, and reviewing validation protocols/reports and developing requirements, revising/creating procedures, authoring MES and software validation / sustainment test cases, executing test cases and maintaining the integrity of the electronic device history record (eDHR).

Requirements

Associate’s degree required in engineering or a scientific discipline or equivalent combination of education and experience
Minimum of 2 years relevant Computerized System Validation (CSV) or 1 year CSV and 1-year relevant Process Validation experience in the medical device / pharmaceutical industry.
Experience with 21 CFR Part 11 and GAMP 5 computer system validation and control requirements.
Experience with 21 CFR Part 820 and ISO 13485.
Experience with manufacturing and quality system principles.
Effective communication (written and verbal).
Ability to follow established procedures.
Attention to detail and commitment to quality.
Strong proofreading and writing skills.
Strong organizational and prioritization skills
Ability to multitask, prioritize, and provide deliverables within the required time period.
Strong computer knowledge (MS Office).
Ability to work as a team member on cross-functional teams and with associates across all levels within the organization.

Nice To Haves

Experience in medical device industry is preferred.

Responsibilities

Develops software validation strategies for new and revised quality system and manufacturing software. Works with the team to provide appropriate guidance and support throughout the projects. Reviews and approves validations, test scripts, and reports.
Supports the continuous improvement of TMC’s software validation and controls processes in accordance with regulatory requirements.
Interprets and provides guidance on appropriate risk-based techniques for software validation and controls.
Functions as an integrated MES team member to support new MES deployments, sustaining, and optimization projects.
Assists with development of MES validation test cases and support Software Verification & Validation activities that include CRS revisions and test case execution.
Supports the maintenance for the compliance of the MES system, the integrity of its validated state, and the eDHR.