Job description

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.

The Jabil Healthcare facility in Clinton, Massachusetts is one of the most unique manufacturing office settings in the world. Encased in a brick carpet mill from the 1840s is 95,000 square feet of cleanroom manufacturing and expansive office spaces.

The manufacturing complex offers a wide range of capabilities to support all steps in our customers' product lifecycle, including product design, mold manufacturing, tooling, precision injection plastics molding, semi-automated and fully automated assembly, and final packaging. The site also provides product distribution and supply chain management for our customers.

SUMMARY
Our Quality Systems Engineer, CSV Specialist is an entry level position that functions as an administrator for QMS and training software systems at the site. You will manage and maintain multiple QMS/LMS systems to comply with applicable regulatory and customer requirements. You will also establish and maintain CSV requirements for software systems used at the site.

IN YOUR ROLE YOU WILL
 Develop and maintain procedures/documents for software validation activities.
 Maintain master software application listing which identifies the software used by site.
 Lead periodic review process of user access list for software systems used at site.
 Coordinate with IT when hardware/software upgrades/updates are needed.
 Assist users with software validation activities.
 Develop to be a computer software validation SME for the site.
 Develop to be a data integrity SME for the site.
 Site Admin for QMS/LMS software systems.
 Approve/Review/Author documents such as User Requirement Specifications, Validation Plans, Risk Assessments, Test Protocols/Reports, Validation Summary reports.
 Ensure complaints use of Change Notices for documentation submission/changes.
 Participate in problem-solving and process improvement activities.
 Support all programs and initiatives related to the Jabil Healthcare Ethics code, Values and Sustainability programs.

MINIMUM REQUIREMENTS

• Bachelor's degree preferred.
• 1-2 years of software validation experience, preferably in the medical device or pharmaceutical industry but any industry knowledge is acceptable. Knowledge of ISO 13485 and FDA part 820 is preferred.
• Excellent attention to detail, follow through and organizational skills.
• Must be self-motivated and able to work independently with minimal supervision/guidance.
• Preferred demonstrated working knowledge of CSV practices and requirements in a regulated medical device manufacturing environment (21 CFR Part 820,21 CFR Part 11, ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP),etc.).

Job Type: Full-time

Pay: $65,000.00 - $73,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Relocation assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Clinton, MA 01510: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Systems engineering: 1 year (Preferred)
• ISO 13485: 1 year (Preferred)
• Software Validation: 1 year (Required)

Work Location: One location

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