Quality Software Engineer

JOB OBJECTIVE: This position will support both existing and future Quality System processes that are managed by EtQ Reliance, SAP and other non-product software. Serves as a back up to the EtQ Reliance system administrator. Provides support to the ongoing extension and improvement of EtQ Reliance (EtQ) and other non-product software projects.

CORE DUTIES:

Assists in implementing, improving, and maintaining the electronic quality management system by performing the following:

1. Acts as EtQ Reliance system administrator.

2. Participates in cross-functional projects to implement the electronic quality management system including user requirements, design specifications, traceability matrixes, software configuration, testing, verification, and validation.

3. Participates in continuous improvement activities aimed at reducing activity delays, eliminating redundancies, and increasing throughput.

4. Aids in quality system monitoring and continuous improvement activities by developing and maintaining reports utilizing report writing tools such as Business Objects, Crystal Reports, or Cognos to present quality data and analyze data for trends and opportunities for improvements.

5. Participates in efforts to resolve software issues and meet business requirements by collaborating with end-users, information systems staff, software vendors and service providers.

6. Participates with technical staff and end-users in developing and maintaining technical and end-user documentation.

7. Participates in efforts with business areas and information system staff to configure and manage software systems in development, test, and production environments as part of the software lifecycle.

8. Analyzes, designs, develops, documents, tests, implements, supports and maintains quality software systems.

9. Performs software design and code reviews for other developers.

10. Creates standard operating procedures, training plans, validation scripts and other user documentation.

11. Supports new product release process through expertise in the software system to gather new product requirements.

12. Runs queries on complaints for complaint investigation, product teams and CAPA/Management Review.

13. Represents Promega in discussions/interactions with partners, vendors, or customers during external audit.

14. Provides support to Promega’s quality system by assisting QA/RA and other departments in quality system improvement activities.

15. Participates in system deployment, which includes the evaluations, testing and installation of new and upgraded software or hardware products.

16. Participates in system deployment, which includes the evaluations, testing and installation of new and upgraded software or hardware products

17. Other duties as assigned.

18. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

19. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

20. Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.

21. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. BA or BS in science, business, IT, computer science, or other field is acceptable

2. 1 - 3 years’ experience in a formal software development role, preferably supporting a Quality System.

3. 1 - 3 years’ experience developing and executing system test plans.

4. 1 - 3 years’ experience creating validation scripts.

5. Knowledge of regulations and standards affecting IVDs or other regulated products.

6. Experience configuring, implementing, and maintaining electronic quality management systems such as EtQ Reliance or Pilgrim SmartSolve, including extensive end-user contact.

7. Experience utilizing report writing tools such as Business Objects, Crystal Reports, or Cognos.

8. Adept at solving problems and recommending possible solutions.

9. Technology aggressive individual who seeks to continually improve of their skills and knowledge and easily shares their expertise.

10. Effective written and verbal communication skills.

11. Excellent interpersonal skills.

12. Works well in a team environment, anticipating and meeting team needs, able to work with sufficient direction.

PREFERRED QUALIFICATIONS:

1. Experience with SAP and EtQ Reliance.

2. Experience with Python and SQL code writing and implementing code changes in electronic quality management systems such as EtQ.

PHYSICAL DEMANDS:

1. Ability to use computer programs (Microsoft Office Suite), office tools, equipment.

2. Ability to remain stationary for prolonged periods of time.

Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.