Website Karwell Technologies
Karwell Technologies
Company : Karwell Technologies
Job Description:
- Perform Quality Engineering activities related to product development and ongoing cleanroom build support
- Ensure NPD processes comply to quality system and applicable regulatory standards.
- Update risk management and design control files. Maintain relevant quality documentation.
- Develop and execute test methods validations and qualification plans.
- Support design verification and facilitate process validation and commercialization activities related to multi-site transfer.
- Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing.
- Other duties assigned by Leadership.
Roles & Responsibilities:
- Proficient understanding of medical device operations and/or manufacturing processes. Medical Device experience strongly preferred.
- Relevant experience in product development, quality assurance, and/or related fields
Knowledge and understanding of Engineering and Quality principles, theories, and concepts
Understanding of ISO 13485 - Experience developing, updating, and maintaining technical content of risk management files
- Basic understanding of statistical techniques. Experience using statistical software (i.e. Minitab) a plus.
Education & Experience:
- Experience in test method development including validation and/or fixture development
Solid problem-solving, organizational, analytical, and critical thinking skills. - Bachelor's degree in engineering or Scientific field & 4+ years' experience -OR- Master's Degree.
- Equivalent in Engineering or Scientific field & 3+ years' experience.
- Good documentation and communication (e.g., written and verbal) skills with keen attention to detail.
- Ability to build productive working relationships and interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment.