Senior Quality Engineer
Location: Miami, FL
Working Situation: On Site
Level: Mid-Level
A reputable medical device components company based in Miami, Florida is seeking an experienced and autonomous Senior Quality Engineer to join their team. A successful candidate will be responsible for ensuring that the highest standards of Quality are maintained throughout all stages of the manufacturing process.
The Senior Quality Engineer will be responsible for the following:
- Develop strategies that ensure product safety and regulatory compliance within ISO 13485/ISO 9001
- Lead risk assessment activities associated with new products introduction
- Work autonomously while maintaining high-quality standards
- Collaborate closely with vendors and customers as the main point of contact with a demonstrated ability to effectively communicate needs, deadlines, and updates
- Has the ability to mentor more green team members and demonstrate leadership potential
- Adhering to cGMP standards and FDA guidelines
The Senior Quality Engineer should have the following qualifications:
- Bachelor's degree in Engineering discipline or related field
- Strong background (5+ years) as a Senior Quality Engineer within the Medical Device industry
- Knowledgeable about ISO 13485/ISO 9001 compliance requirements
- Experience working with needles (strongly preferred)
If you are interested in the Senior Quality Engineer opportunity, please apply now!
