The Quality System Analyst is responsible for preparing technical reports for customers. Facilitate management review and associated metrics preparation. This key role must ensure effective interaction with customer representatives and other internal departments regarding product report and metrics preparation. Ensures complete compliance to all applicable statutory and regulatory standards including cGMP/QSR, ISO 13485 and 21 CFR 820, Part 11.
The analyst will use site and system data to produce trend reports which identify systemic issues requiring site corrective or preventative actions. This data will support the Management Review process and the ongoing identification of risk mitigation and continual improvement opportunities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develop, prepare and review required Lilly customer documentation such as Quality Agreements, Customer specs, SOPs,Change authorizations in accordance with internal and external company policy.
- Collect KPI and key process metric data and prepare slide decks weekly, monthly, and annually required for management reviews
- Provide support to Clinton/Devens Production and Project Engineering teams regarding quality issues, measurement data and measurement techniques, statistical methods and analysis, specification interpretation and application.
- Ensure that the molding, assembly, and documentation of medical devices complies with cGMP regulations, including 21 CFR Part 820, 21 CFR Part 210, 21 CFR Part 211 and other international regulatory standards. Includes documentation (Device History Record and Device Master Record), validation protocols (IQ, OQ, PQ), and risk assessment (FMEA).
- Participates as needed in the development, maintenance and site compliance of product Quality Plans (QP) (Assembly and/or Molding), Standard Operating Procedures, Inspection Plans (IP), Batch History Record (BHR), Device Master Record (DMR), etc… as established through local site and customer requirements.
- Participates in commercial support problem solving activities including resolution of area non-conforming product/process events, process change/deviation authorizations, product quarantine events and complaint investigations, etc…
- As appropriate, may be required to directly interface with customers, suppliers, and other local site departmental resources at all levels of these organizations. Communication may include, but is not limited to, complaint investigations, CCN reporting, etc…
- Other duties as assigned by manager
- Analysis of site QMS data to support Mgt Review process. Perform trend analysis on key quality metrics .
- Identify quality system issues and recommend / implement corrective and preventative actions.
- Ability to process CA or PA from audit findings and track issues to closure.
- Track progress of follow-up items from External & Internal audit reports, Mgt Review, Corrective/Preventive Action Requests (8D) and other continuous improvement projects
- Maintain Quality 1st mentality within the organization
- May perform other duties and responsibilities as assigned.
The following are preferred in job candidates:
- BS in a technical or applied science discipline (or equivalent Quality/ Process/ experience), with 3-5 years’ experience.
- Experience in Quality Management Systems (QMS) and functions: Corrective Action and Preventive Action (CAPA), SPC-Metrics preparation and analysis,Material Review Board (MRB), Non-Conforming Material Reports (NCMR), Complaints, Internal and External Audits.
- Experience in industry regulated under standards such as cGMP/QSR, ISO 13485 and 21 CFR 820, Part 11.
- Strong analytical skills that include trending and evaluation of data with the ability to identify potential process problems, risks and opportunities for improvement.
- Excellent computer skills including experience with Word Processing
- Excellent report and presentation preparation skills utilizing MS office or similar tools
- Ability to analyze data, drive root cause using analytical and/or statistical tools
- Ability to correlate QMS performance with product and process quality trends
- Desire to continually improve the efficiency and effectiveness of the QMS
- Understanding of quality system regulatory requirements and how they relate to the business
- Organized self-starter and pro-active approach combined with excellent time-management skills
- Results oriented, with the ability to interact with technical and non-technical personnel
- Strong team player with the ability to communicate at all levels, horizontally and vertically, throughout Jabil
The following are not required but are considered valued skills in job candidates:
- Experience with Minitab, Lotus Notes, NWQS, SAP, Predisys SPC and Adobe Write applications
- Experience working in an ISO 14644 Class 8 cleanroom work environment
- Certified Internal/ Lead Auditor in ISO 13485:2016
- ASQ certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)
- Lean certifications such as Six Sigma Green Belt (SSGB) or Six Sigma Black Belt (CCBB)
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.