software quality engineer.

job summary:
One of our Jacksonville, Florida clients is looking to add a Software Quality Engineer to their team.

 
location: Jacksonville, Florida
job type: Contract
salary: $55 - 65 per hour
work hours: 8am to 5pm
education: Bachelors
 
responsibilities:
Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents.

- Create, review and approve software validation documentation.

- Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews.

- Review and approve internal and vendor software packages and test documentation.

- Prioritize and plan all assigned projects for the software validation department.

- Implement new or changed programs/policies/procedures related to CSV and support SDLC & software validation policies, procedures and processes for computerized systems.

- Facilitate change validation as part of the Change Control Board (CCB) as the SQE representative.

- Lead the Installation Qualification (IQ) of manufacturing lines.

- Support CSV improvement initiatives in manufacturing.

- Champion cross-collaboration across functions, sites and operating companies in the area of CSV.

- Identify and resolve barriers that impede business needs.

- Collaborate with Franchise Quality in the deployment (design, implementation, and post-monitoring) of Quality System initiatives impacting the site that promote the continuous improvement of the Quality System and ensure continuity of the application of globally shared processes and systems at the site level.

- Support compliance activities by participating in audit readiness, support internal and external audits pertaining to CSV.

- Serve as the Subject Matter Expert for CSV and manage investigations, responses, and remediation of site-specific CSV audit observations

 
qualifications:
Qualifications

- A minimum of a Bachelor's Degree is required, preferably in Engineering, Computer Science or a related technical field.

- A minimum of 3 years of experience in a regulated environment is required.

- Working knowledge of FDA and European medical device regulations (QSR and ISO) is required.

- Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System is required.

- Working knowledge of GAMP5 and SDLC is required.

- Working knowledge of regulations for electronic records, electronic signatures, and data integrity is required

- Experience with change management and a strength with technical writing is required.

- Experience with SCADA and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations is required.

- Medical device process validation experience is preferred.

- Experience in Quality Auditing and notified body inspections is preferred.

- Experience in Quality Systems process development, support, integration or enhancement is preferred.

- Experience with training or coaching others is preferred.

- Software Quality Engineer certification (CSQE) or Quality Engineer certification (CQE) is preferred.

- This position will be based in Jacksonville, FL and will be onsite

 
skills: Working knowledge of FDA and European medical device regulations (QSR and ISO) is required.

SAP



Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.