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| POSITION / TITLE: |
Quality Assurance Engineer |
| DEPARTMENT: |
Regulatory Affairs/Quality Assurance |
| REPORTS TO: |
QA Director |
| LOCATION: |
US/Carlsbad |
Position Summary:
This position participates as a member of the QA group. With minimal supervision analyzes and observes manufacturing processes to develop and install quality control methods, practices and procedures for a designated area of a manufacturing operation. Analyzes customer feedback, recommends, implements and tracks associated quality improvements activities and reports on effectiveness. Plans, schedules, initiate and follow up quality engineering methods, procedures, and systems to improve and maintain product quality. This position will also assist in performing other tasks within the Quality Department related to maintaining the Quality System.
Duties and Responsibilities: (not totally exclusive to the following)
- Conducts assigned engineering studies utilizing advanced statistical methods and techniques to solve quality problems.
- Provides quality engineering guidance on process characterization and process capability during validations and supports root cause investigations on production issues when required.
- Recommends dimensions and characteristics to be inspected and techniques to be followed.
- Responsible for working with the manufacturing and R&D teams to develop and revise inspection testing, in process and finished product testing.
- Works with the manufacturing engineering, R&D engineering and clinical teams in analyzing customer complaints including identification of root cause and implementation of corrective / preventative action. Prepares associated documents, findings and reports.
- Participates in product design, manufacturing process and clinical use risk analysis and failure modes and effects analysis (FMEA) for both the disposable device and instrument.
- Prepares and executes process validations and accurately documents test results and maintains applicable Quality records.
- Provides support of timely calibration of measurement and test equipment.
POSITION QUALIFICATION REQUIREMENTS:
- Minimum requirements include a Bachelor’s degree in Engineering or a technical discipline; or equivilent experience.
- Experience applying statistical techniques in a process development and manufacturing environment.
- Experience working in a start-up or small medical device company environment, preferred.
- ASQ certification for Quality Engineering preferred.
- High level of analytical ability and troubleshooting skills where problems are unusual and difficult.
- Understanding of engineering theory and principles of design.
- Effective oral and written communications skills. High level of interpersonal skills, demonstrated ability to work independently and with others.
- Troubleshooting and technical problem solving ability.
- Understanding of experimental design and statistics.
- Good understanding of the requirements of CFR820, Quality System Regulations and ISO13485 directives.
- The ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech and demonstrated comprehension skills.
- Good teamwork and ability to work cross functionally within the company.
- Must be able to maintain regular and predictable attendance.
PHYSICAL JOB REQUIREMENTS: ESSENTIAL JOB TASKS/FUNCTIONS
Review the duties/responsibilities and other requirements for this position. Identify the physical requirements that are necessary to fulfill the job objectives. Once identified, answer the following questionnaire in view of the factors that relate to whether a job task (requirement) is essential or not. Use your best judgment. This information is used for Affirmative Action Planning and Americans Disability Act.
Answer with a yes (Y) or no (N) to each requirement listed
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