By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers' success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
QA Engineer with experience in medical industry, knowledge in, project management, validations, FDA requirements ISO:13485, QSR 820, statistical analysis, Root cause analisis/problem solving, MSA, Control Plans, clean rooms.
Position scope/summary
- Develop, implement and monitor systems and procedures of quality assurance.
- Perform statistical analysis in the areas of manufacturing, receiving inspections and testing to detect trends and problem areas.
- Conduct investigations and projects that will improve process or quality procedures.
- Under general supervision, the Engineer independently solves routine problems and develops solutions in more unusual situations.
- Recommends modifications to methodology, understands the impact of these modifications on the broader engineering area, schedules and performs validations and provides guidance to individuals in more junior positions.
- Must be able to interact with employees outside of his or her immediate work group and provide effective communication both orally and written in English and the language of the outside group.
- The QE is responsible for the follow up to customer complaints.
As process owner the QE will coordinate all activities for the proper & timely closure of customer complaints.
Essential duties and responsibilities
- Works in conjunction with the validation team.
- Audit the collection of statistical data for correctness and accuracy.
- Analyze negative trends and identify corrective actions.
- Study new technology in methods, equipment and materials that may enhance the current processes.
**Qualifications**:
- Bachelor's degree
- Familiar with computer programs such as: Excel, Word, Access, Statistical programs, Basic and advanced statistics (Minitab)
- Root cause analysis
- Validations (IQ/OQ/PQs)
- Validation of test methods (TMVs Gauge R&R)
- Knowledge in measurement equipment analysis (MSA)
- 85% fluency in English
- Ability to work in groups.
- Three years of experience in the areas of quality control and manufacturing
U.S.
Applicants: EOE/AA Disability/Veteran