DUTIES & RESPONSIBILITIES
- Oversee and manage design transfer and process transfer activities for lithium-ion battery manufacturing
- Provide engineering support and lead troubleshooting activities on the production line. Perform systematic and documented Root Cause Analyses for failures and implement Corrective Actions.
- Perform analysis to understand and improve processes, reduce failures, and improve yields.
- Participate in design reviews and pre-validation assessments of new products and processes, and ensure the process has adequate and appropriate process controls and documentations.
- Work with Product Development team to ensure all aspects of Design Transfer activities are being met and comply with the requirements of the quality management system and external regulatory agencies
- Ensure that all equipment, instrumentation, and software is maintained in a validated state. Ensure compliance with current regulatory requirements.
- Review proposed changes by performing risk assessments, providing guidance, support, and assessing the adequacy of verification and validations and DHF documents
- Participate in and author sampling plan development and data analysis for design verification, new/existing product test methods and incoming inspection; ensure predetermined requirements are met
- Communicate results effectively, guiding the team through data and observations on critical process decisions.
- Coordinate with cross-functional project teams to ensure timelines are met and assist the team to balance costs, timeline, and performance.
QUALIFICATIONS
- Bachelor’s degree (B.S.) or Masters degree (M.S.), preferably in a scientific discipline or life sciences
- Strong analytical, planning, and organizational skills
- Technical and administrative abilities required to carry out routine job requirements.
- Excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management.
- Ability to communicate ideas and knowledge effectively and clearly to other individuals and teams.
- Excellent problem-solving skills
- Self-starter with ability to work independently under pressure and react quickly to changing priorities
- Mentor team members in qualification/validation technical aspects, and compliance requirements
EXPERIENCE
- Eight (8) years minimum direct applicable experience, with relevant experience in AS 9100D or ISO 9001 regulated environment
- Working experience in Li ion battery industry with knowledge of ISO and AS 9100D guidance documents and regulations and standards
- Thorough understanding of industry regulations ISO QM Standards.
- Knowledge of design control principles
- Thorough understanding of Statistical Methods for Quality Assurance
The role of the Manufacturing QC Manager is to manage and maintain the company's quality system and standards. Knowledge of industry and governmental quality regulations is needed to conduct activities involving quality control, assurance and compliance with applicable regulatory requirements. This personnel will oversee and manage design transfer and process transfer activities, conduct internal audits, review quality data according to existing documents and procedures, and initiate corrective actions as needed. In addition, this role will champion continuous improvement throughout the organization. Acute attention to detail and regular communication with the design team and production team are a must.