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