Vacancy expired!
- Lead the review of all material review board dispositions within functional area
- Read, comprehend and follow documents outlining all procedures related to the light adjustable lens
- Establish and maintain document control practices for the manufacturing area including batch records, data systems, and material release
- Create, review, and maintain risk management files within functional area
- Review test results and release material for use
- Establish and maintain material control practices for the production area
- Perform audits of manufacturing practices to confirm operations to established processes
- Maintain and update equipment development, validation, and installation process
- Control materials for use in manufacturing and non-conforming materials
- Work with suppliers to ensure quality system requirements are understood and successfully met
- Maintain compliance to latest standards for optics, electronics, mechanics, and software as required
- Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11
- Knowledgeable of ISO 13485 and 14971
- Knowledgeable of IEC 60601-1
- Knowledgeable of requirements for medical devices in US, EU, Mexico, Canada, Australia, and other markets
- Able to perform product failure analysis
- Able to perform basic statistical analysis
- Strong interpersonal skills, well-established computer, communication and presentation skills
- Able to run complaints, CAPA, training, non-conformances, change control, engineering change requests, and other quality systems
- BS degree in an engineering or science discipline or combined education and experience.
- Minimum of 5 years of experience performing quality assurance/regulatory affairs and developing processes in a manufacturing and/or product development environment preferably in the medical device industry.
- Health insurance
- Casual Dress code
- 401k match
Vacancy expired!