Department: Azzur San Francisco LLC
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications, and be a factory-focus team member.
- Perform return product investigations for product complaints.
- Monitor manufacturing quality rates and develop reports to communicate performance for manufacturing lines.
- Perform key deliverables in support of development and continuous engineering R&D projects, which may include: mold tool qualifications, component qualifications, design and product risk assessments, shelf life validations, and sterilization validations
- Work with manufacturing and R&D engineers to prepare work instructions, material specifications, and inspection documentation for new products. Set inspection requirements, set inspection methods and inspection sampling plans.
- Support and test component changes to current products.
- Support internal audits and supplier audits.
- Bachelors degree in Engineering
- At least 5 years’ experience of quality experience in a regulated, manufacturing environment within the medical device industry.
- ASQ-CQA certification
- Must have previous experience using Master Control
- Strong communication skills