Communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions.
Work on continuous improvement activities. These may include participating in, and/or leading Quality Improvement Teams.
Provide quality reports and review trending on assigned areas of responsibility.
Conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, supplier quality issues, calibration out of tolerance conditions, and CAPAs (internal or audit CAPAs).
Review and approve documents and drawings for manufacturing and product development (DCOs, MCs).
Support to Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of products.
Design gauging and develop tools and techniques to measure product parameters to assure product complies with engineering drawings.
Recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities.
Develop and document Quality Plans to support product acceptance activities.
Facilitate creation of risk management documents.
Ensure compliance issues are addressed for product activities.
Participate on design reviews and risk analysis for product changes.
Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness.
Review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval.
Provide guidance to others for the generation of clear, concise and defendable protocols and reports.
Assist in determination of the need for validation.
Manage process monitoring activities including tracking, data collection and analysis, corrective action, and reporting.
Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s).
Coordinate and participate on supplier audits and technical assessments.
Assist purchasing with identification and qualification of suppliers and alternate manufacturing locations.
Administrate Supplier Management Program and measures effectiveness.
Manage Supplier CAPA activities including root cause analysis, definition of corrective actions and verification of actions.
Coordinate Quality Plans and inspection/test methods between suppliers and Synthes.
Visit suppliers for the purpose of quality issues investigation and capability analysis.
Assist purchasing in resolution of supplier complaints.
How will you get here?
Preferred Qualifications
o A minimum of 1 year (professional, internship, co-op, etc.) experience working in a quality system framework (ISO 9001 or similar).
o Medical device/diagnostic/or pharmaceutical industry experience.
o Knowledge of FDA’s QSR and ISO regulations.
o Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development.
o Knowledge of Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments.
o ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification.
o Knowledge of Manufacturing materials and removal processes (machining, sheet metal, electro polishing, passivation, hard coating, cleaning, adonization, etc.).
Required Qualifications
o A minimum of a Bachelor’s degree in Sciences, Business, Engineering or related technical field.
o Ability to manage multiple projects/requirements in a fast-paced environment.
o This position will be located in Elmira, NY and may require up to 10% travel including potential international travel.
BENEFITS PACKAGE WITH JABIL
Competitive base salary
Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
401K match
Employee Stock Purchase Plan
Paid Time Off
Tuition Reimbursement
Life, AD&DJBL TA - Job Requisition Process Status, and Disability Insurance
Commuter Benefits
Employee Assistance Program
Pet Insurance
Adoption Assistance
Annual Merit Increases
Community Volunteer Opportunity
The pay range for this role is $58,800 - $94,100. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.
As part of the total rewards package, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purchase plan; and paid time off.
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.
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 or calling 727-803-7988 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.
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