Qc Manager
2 weeks ago
Responsibilities:
- Provide leadership and manage a team of Quality Specialist and Manufacturing Doc Specialist, and Technicians to perform QC activities and achieve pre-determined quality objectives set by the company
- Establish and manages QC systems that will enhance and maintain products that meet quality specifications and standards for product release.
- Develop resource planning, deployment, budget planning and oversee department spending management
- Establish QC strategy, approach and execution for leading and directing the QC team to align and achieve business goals and objectives.
- Establish, implement and maintain high level of compliance on QC process procedure to meet established quality standard, QMS and remains compliant not limited to ISO13485, MDSAP and cGMP.
- Provide QC oversight, technical expertise and leadership across all aspects of product manufacturing from raw materials, through warehouse activities, engineering, quality control, manufacturing and operations support
- Establish and manages Plant manufacturing document control processing activities to meet with QMS requirements.
- Collaboration efforts with internal stakeholder(s) to resolve any issues related to QC process and issues that may impact critical system and product release and drive achievement of department and plant goals.
- Prepare product/process quality reports by collecting, analyzing, trends and report periodically direct to Management on performance relating to quality processes.
- Participate in activities for new product introduction and product transfer to insure proper production start-up. Review products for DFX practices.
Qualifications:
- Bachelor’s degree in Engineering or equivalent in a related field
- Minimum 8 years of Quality roles in medical device industry with minimum 3 years managerial or supervisor duties.
- Knowledge of manufacturing processes, quality engineering, documentation data management
- Highly self-motivated with influential management skills
- Strong customer orientation and focus
- Exhibits analytical thinking and committed to drive teams to meet business goals
- Strong knowledge of QMS requirement on ISO13485, MDSAP, FDA 21 CFR Part 820
- Working knowledge of SAP and Product Lifecycle management methods a plus
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