Quality Engineer Medical Device jobs
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Job Post Details
Supplier Quality Engineer
Job details
Full job description
SUMMARY
To be a technical focal point to monitor and work supplier quality issues directly with the manufacturer and communicate status on non-conforming parts/suppliers across all programs. Evaluate supplier performance, determine appropriate Inspection processes and provides guidance to Receiving Inspection function at the site level.
Responsible for maintaining a controlled documentation system, record retention, and information services function, including electronic records retention processes.
Prepares and reviews required documentation such as good manufacturing practices (GMP), procedure manuals, quality control manuals, engineering documents, manufacturing instructions, change authorizations and forms in accordance with company policy and government regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Performs the supplier qualification process and activities for new suppliers, changesand exits. Ensures maintenance of supplier qualification and supplier re-evaluationdocumentation.
- Releases and maintains the Approved Supplier List.
- Support audit request providing supplier quality data and supplier point of contacts to Supplier Audit team.
- Lead and execute supplier risk assessments (e.g., as result of supplier audit or SQArefusals, poor performing suppliers, supplier qualification and re-evaluation).
- Lead and execute Supplier Quality Agreements (new creations, sustaining).
- Performs the maintenance of the Quality Record retention process.
- Performs the maintenance of SharePoint and data bases related to SupplierQualification process and Scorecard dashboard.
- Analytics and data reporting to support supplier metrics, dashboards and supplier andquality management reviews, Jabil internally and with customers.
- Ensures compliance with cGMP, EN ISO 13485, 21 CFR 820/201/211, EuGMP andFDA/Regulatory requirements for the Quality System.
- Supports regulatory, customer, and internal inspections/audits, act as SME for SupplierQualification, re-evaluation process and ASL management activities. Implementscorrective actions as needed related to Supplier Qualification process.
- Support all company safety and quality programs and initiatives.
- Ensure compliance with all learnings from all GMP training events.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes
- Serve as the focal person for commodity related quality and functional issues that stem from components being purchased for manufacturing.
- Ensure that all production critical supplier issues are resolved in a timely manner, and corrective actions are implemented correctly.
- Serve as the point of contact for Inspection Plans and Inspection Methods, and provide guidance to Receiving Inspection Auditors.
- Ensuring ongoing site supplier evaluation is performed. This would be achieved by using site information collected from Receiving Inspection, MRB, Customer Returns, SCAR database and by liaison efforts with customer work cells. Performance will be reported internally, to the supplier, and to the customer where applicable.
- Perform supplier audit interfacing with Corporate SQE if applicable.
- To provide documentation to perform Inspection of components per Inspection Plans in SAP.
- Monitor and drive PPM issues with the supply base in addition to helping them achieve “Dock to Stock” certified with Jabil (in accordance to the vendor performance system).
- Drive supplier selection strategies that will yield a supply base that can be used across all customer programs providing leverage cost savings.
- Proactively communicate information or issues that may impact the product costs of manufacturability to all affected departments.
- Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor. Comply and follow all procedures within the company security policy.
MINIMUM REQUIREMENTS
Bachelor's degree required, bachelor’s degree in Engineering preferred; and 3 to 4 years of experience in experience in a similar role ideally regulated environment or Manufacturing Engineering; or equivalent combination of education and experience.
LANGUAGE SKILLS
Advanced PC skills, including training and knowledge of Jabil’s software packages. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
MATHEMATICAL SKILLS
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Individual may be required to sit, stand walk regularly, and occasionally lift up to15 lbs. Be accessible to production floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Individual’s primary workstation is located in the office area, with some time spent each day on the manufacturing floor. The noise level in the work environment ranges from low to moderate.
Minimum Language required
- English German
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 identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.
Accessibility Accommodation
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 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.#whereyoubelong