Katalyst Healthcares and Life Sciences
Job Location :
Marion,NC, USA
Posted on :
2025-01-29T19:37:29Z
Job Description :
Responsibilities:
- Leads or assists in developing and implementing new machines/processes and in improvements to existing methods.
- Qualification requirements for new/improved machines/processes, including system requirements/ design specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Senior Quality Engineer.
- This requires interfacing with local Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions.
- Supports the manufacturing plant through implementation of process improvements.
- Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, VIP measurements and implements/drives improvements.
- Manage small projects (both new and improvement) to include cost, implementation, and validation.
- Provides statistical assistance to Quality and Production.
- Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.
- Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
- Composes protocols, final reports, studies, experiments, and general information reports for use by management.
- Leads/coordinates validation efforts of new equipment and changes to existing equipment.
- Assist in evaluation of customer complaints, risk management and technical summaries.
- Assist in evaluation of supplier product/process changes.
- Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP's, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485-2003, and other applicable standards and regulations.
- Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
- Supports and may own execution of CAPA investigations with use of DMAIC process and technical writing skills.
- Excellent Technical writing skills, especially as it relates to the CAPA/Complaint process and the actions associated with those activities.
- Understanding and knowledge of various international standards relating to a variety of topics, as needed (i.e. ASTM, ASRAE, ANSI, AAMI, ISO standards applicable to scope of work) .
- Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
- Identifying problems relating to the product, process and quality system.
- Initiating and implementing solutions through designated channels.
- Establishing controls on a process and establishment of the verification/monitoring of such.
- Driving improvements into the production process, from conception to sustainable production methods.
Requirements:
- Minimum 6 years of experience in regulated manufacturing environment.
- BS degree in Engineering preferred, Engineering Technology / Biology / Microbiology/Chemistry degree may be acceptable depending on experience.
- Strong technical writing and investigation skills required.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.
- Familiarity with MINITAB preferred.
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