Jabil Quality Systems Engineer in Clinton, Massachusetts
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.
This position has the responsibility and authority to participating in the development, documentation, maintenance, and improvement of Customer Complaint Program. The incumbent will be responsible for ensuring continued compliance to associated regulations, standards, and corporate policies. Additional responsibilities include supporting internal and external auditing programs, Quality Management System elements as required.
Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):
Customer Complaints Program
Facilitate CC process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485, ISO 14971 & FDA 21 CFR part 820), Jabil Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
As a CC coordinator, quality engineer shall facilitate efficient and effective processing of CCs
Regularly communicate with Engineering, Quality, and manufacturing to implement robust CC within defined timeline.
Track and Trend CC metrics including but not limited to weekly and monthly CC metrics
Coordinate with cross-functional team for root cause analysis and corrective & preventive actions
Conduct Verification of Effectiveness for the CCs
Participate in CC Review Board meetings and get required support from senior management team for CC implementation
Complete harmonization and gap assessment reviews for documents associated to CC process
Facilitate meetings with customer to support closure of open CCs and respond to customer queries
Facilitate investigations on Return Material Authorization requests submitted by customer
Assists with internal audits, external audits, and FDA inspections
Participates in Second/Third party audits and provides input to Jabil response to any findings
Quality Engineering Support
As required, assists in development of quality plans, work instructions, procedures, harmonization, periodic document reviews, change controls, process change authorizations etc.
May perform other quality related duties and responsibilities as assigned
Job Specifications: The minimum education and experience required to perform this job competently.
B.S. in a Technical or Applied Science discipline (or equivalent Quality / Process / Project / Automation / Injection Molding experience), with 0-3 years engineering experience. No experience in a supervisory category is required.
Must have strong verbal and written communication and interpersonal skills
Organizational and planning skills are required to plan, execute, and track quality commitments
Strong problem-solving skills
Understanding of project management (experience preferred)
Ability to multitask and perform efficiently and independently
Knowledge of various quality system methodologies such as 8D, Lean, 5 Why’s, Pareto Analysis, PFMEA, PPAP etc. preferred
Internship / experience in the regulated industry with standards such as cGMP/QSR, ISO 13485 and 21CFR 820 Part 11 preferred
The following are not required, but would be considered valuable skills/experience in potential candidates:
Experience working with medical devices, combination devices, and/or pharmaceutical delivery systems
Experience with Minitab, Lotus Notes, SAP, SPC and Microsoft Office Applications
ASQ certifications such as Certified Quality Engineer CQE or Certified Quality Auditor CQA
Lean certifications such as Six Sigma Green Belt SSGB or Six Sigma Black Belt SSBB
Organization Linkages: List the titles of individuals and organizations with which this position has the most frequent and significant contact. Briefly describe the nature of those contacts.
Department Staff Member
Site Quality Lead and Senior Site Management
Work Cell Manager and Site Department Managers
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.
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.