The Quality Engineer will be responsible for working in a multi-discipline team for the design and development of various quality standards. This position will include developing and modeling component quality SOP's supporting daily production of existing product manufacturing as well as the support of new product development and introduction. This role requires a strong sense of self accountability and discipline.
- Bachelors degree in Mechanical, Biomedical, or related Engineering discipline with 3+ years experience working as a quality engineer within the Medical Device or Pharma/Life Sciences industry.
- Three plus years working with QA
- Experience working with CAPA's
- Medical Device Experience
- Three plus years working with Validation processes
- IQ/OQ/PQ experience
- NOVA or other QMS systems
- Risk Management Experience
- FMEA Experience
1st Day Expectations:
- Prior experience developing and executing CAPA plans.
- Previous experience executing on root cause analysis
- Experienced in performing Validation and Test Method Validations for product and/or process's for manufacturing in the medical device industry (IQ/OQ/PQ)
- Must have experience working within FDA regulated manufacturing environment
- Experience working in an ISO 13485 environment
- Ability to work in a fast paced environment, working with multiple projects (3-6) at any given time.
- Experience and knowledge around GD&T
Highly regulated class 2 and 3 medical device manufacturing facility for various tissue and bone implants. One of the largest medical device manufacturers in North Central Florida. Team driven environment that is geared toward providing the highest quality implantable devices possible.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.