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Site Quality Manager

Req ID: J2286195

  • Location
    Maple Grove, Minnesota, United States of America
  • Category Quality Group
  • Posted Tuesday, September 7, 2021
  • Time Type Full time
  • Job Type Permanent Employee

Job Description

SUMMARY
Drive continuous improvement through the development and implementation of Quality processes, systems, tools and techniques. Provide exceptional support to customers, team members, and shareholders.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.


·         Drive continuous improvement through trend reporting analysis and metrics management.
·         Assess the adequacy of data gathering methods utilized by the workcells.
·         Assure that procedures and work instructions are efficient and not redundant.
·         Offer new ideas and suggestions for improvement. Identify and implement new practices and processes that are “best in field.”
·         Demonstrate a commitment to customer service; anticipate, meet, and exceed expectations by solving problems quickly and effectively; making customer issues a priority.
·         Understand and drive regulatory and compliance certifications as appropriate (i.e. regulatory requirements surrounding ISO9000, ISO14000, QS9000, BABT, TUV). Act as the company’s quality management representative (QMR).
·         Establish new measurement systems if/where possible.
·         Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization.
·         Ensure 100% adherence to all company policies and procedures (i.e. Health and Safety, Quality).
·         Ensure all sensitive and confidential information is handled appropriately.
·         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.

KNOWLEDGE REQUIREMENTS

  • 10+ years or related experience in manufacturing; experience medical device, contract manufacturing or relevant manufacturing environments required.
  •  Strong understanding of the requirements specified by the FDA (21 CFR’s), ISO (13485, 14971,14644, 9001).
  • Experience using Lean Six Sigma and Lean Manufacturing concepts.
  • Knowledge of applied statistics in manufacturing including SPC, SQC, process capability and control limits.
  • Experience in cleaning, disinfection and sterilization validations preferred.
  • Experience in water systems, bioburden and LAL endotoxin testing preferred.
  • Experience with particulate counters, surface sample and air impactor preferred.
  • Experience in water microbial & chemical content; distilled, RO, DI etc preferred.
  • Experience in regulatory complaint investigations, CAPA and Non-Conformances.
  • Experience in ISO Class 8 Certified Cleanroom and Controlled Environment.
  • Microbiology experience in medical devices, industrial, and food preferred


MINIMUM REQUIREMENTS
Bachelor’s degree and 10+ years experience, including 5 years in a managerial role required.

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 https://careers.jabil.com/ 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.

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