Experience and Skills:
- Bachelor’s degree in Engineering or Science related field; or
- 3-5 years’ experience working within Quality Systems/ Engineering.
- Experience working with business management systems, particularly
with ISO 13485 preferred, and FDA Title 21 CFR Part 820, QSR.
- Self-Motivated analytical data driven decision maker with strong
- Strong commitment to quality and customer service.
- Demonstrated problem solving skills required.
- Ability to lead and influence others by example in the areas of
attitude, work quality, work ethic, dependability, and company loyalty.
- Able to solve practical problems with a variety of variables in
situations where only limited standardization exists.
- Able to read, analyze, and interpret government regulations,
reports, and general business reports.
- Able to write business correspondence, reports, internal
procedures, and instructions.
- Strong written and verbal communication skills.
- Able to effectively present information and respond to questions
from customers, managers, and employees.
- Must be able to pass a background check.
The physical demands described here are representative of those that
must be met by an employee to successfully perform the essential
functions of this job. Reasonable accommodations may be made to enable
individuals to perform the essential functions.
While performing the duties of this job, the employee is frequently
required to stand, walk, sit, and operate a computer. The employee
must be able to communicate with speech and hearing. Specific vision
abilities required by this job include vision, distance vision.
Office environment with business casual dress. May require business
attire. Some travel may be required.