ROLE AND RESPONSIBILITIES
In this role, you will be responsible for all activities involving equipment and software Factory and Site Acceptance Testing (FAT and SAT). The successful candidate will be familiar with Acceptance Testing concepts and practices. Be able to apply judgment based in sound quality principles to plan and accomplish goals. Our team of automation, test, software and reliability engineers will rely on you to show consistency and experience in Good Manufacturing Practices and documentation techniques, have good working knowledge of CAPA systems, 21 CFR Part 820 and ISO 13485. A wide degree of creativity and latitude is required and has the ability to work cross-functionally with several internal teams.
- Coordinate, manage, document and lead equipment acceptance programs
- Ensure ongoing compliance with quality management system
- Develop and execute FAT and SAT protocols for manufacturing systems, and equipment
- Write reports summarizing results and statistics for all equipment and process acceptance projects
- Route and track protocols and reports through final sign-off
- Provide input to the validation team for IQ/OQ/PQ protocols.
- Apply technical expertise and knowledge of the FDAs GMP regulations), ISO 13485 and risk management (ISO 14971) throughout these activities
- Interface with suppliers, partners and contract manufacturers on a regular basis
- Ability to travel on and off-shore to manufacturing sites
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 8-10+ years of related experience in Validation or Acceptance Testing in the pharmaceutical/medical device industry or consumer electronics industry
- Experience with high volume automation equipment is desired but not necessary
- Thorough knowledge of best practices for equipment Acceptance Testing and Equipment Validation
- Technical writing proficiency (e.g., protocols, analytical reports, DCOs, SOPs, Test Methods, procedures)
- Practical knowledge of SPC, process capability, Gage R&R, DOE, and FMEA and other quality engineering tools such as statistical data analysis, and inspection techniques.
- Solid problem analysis and decision-making ability and leadership skills
- Computer literacy with preference to Microsoft Professional Office Suite and/or Google Productivity pack
- Excellent verbal and written communication skills
- Strong organizational skills along with strong attention to detail
- Ability to work both independently and collaboratively with small, cross-functional teams.
- Bachelor's degree in Engineering or related field
Vapor, JUUL, Work Culture, Fast Paced, Start-up, Growth, Vape, Technology, Software, Hardware, Consumer Electronics, Manufacturing, Design, Product, Disruptive, Revolutionary, Cutting Edge, App, Android, eCommerce, B2C, Suzhou, China