Software Quality Engineer

Job#: 2070583

Job Description:

Apex Systems is searching for a Software Quality Validation Engineer to work for our client, a global leader in the medical device manufacturing space, in the Jacksonville, FL area.

For immediate consideration, please send a copy of your resume to Jenny DeMaria at and reference Job ID #2070583.

The Software Quality Engineer (SQE) will be responsible for providing software quality and validation support for the companys SAP Fusion systems and related interfaces.

The SQE Consultant will:

• Perform software periodic reviews for GXP software in the Jacksonville, Florida site.
• Provide Independent Quality Assurance guidance based on global regulations and company standards and procedures.
• Partner with testers to ensure all proposed software changes are tested thoroughly and appropriately before approval and issuance.
• Review and approve change requests and software validation documentation.
• Ensure all software validation and change control activities are executed and documented in compliance with regulatory requirements, global and company requirements, and meeting all customer and business needs.
• Partner with internal clients to ensure compliance with GxP computer systems lifecycle procedures, tools, and methodology.
• Support the resolution of testing deviations / defects, including root cause analysis, corrective action implementation and testing, and proper documentation of all associated activities.
• Adhere to environmental and safety policies and procedures and support department's safety and environmental objectives.

Requirements:

• Previous experience working with software validation and compliance activities in a GXP regulated medical device / biopharmaceutical environment; in one or more of these areas:
• Manufacturing automation (i.e. PLC-controlled automated lines, machine vision systems)
• Computerized laboratory instruments (i.e. HPLCs, GCs)
• IT Enterprise software (i.e. LIMS, MES, ERP)
• Ability to work within a global team and handle multiple priorities effectively.
• Knowledge of Systems Development Lifecycle (SDLC) as it applies to computer software for FDA regulated industry.
• Thorough knowledge of US 21 CFR Part 820 and 21 CFR Part11 regulations, ISO13485, EU Annex 11, FDA and international Data Integrity Guidelines, and FDA's General Principles of Software Validation.
• Expertise with Agile and Waterfall software development & testing methodologies.
• Excellent understanding and application of principles, concepts and practices of Risk Management, Validation, Root Cause Analysis/Failure Investigation.
• Excellent written and verbal communication, interpersonal, conflict management, and organization skills.

Highly Desirable:

• Experience performing computerized systems periodic validation reviews in GXP regulated industry.
• Knowledge of Corrective and Preventive Actions (CAPAs) in FDA regulated industry
• Knowledge of LIMS, specifically LabVantage
• Knowledge of automated testing tools (i.e. HP Applications Lifecycle Management, JIRA XRay)
• ISTQB Foundation (CTFL) or Advanced (CTAL) certification
• ASQ / CSQE certification

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6 months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.

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