|
|
 |
|
| Home » About Us » Careers » Quality Engineer |
|
Careers
Title: Quality Engineer
Salary Grade: TBD
Reports to: Director of Quality Assurance
Job Summary:
The quality engineer provides expertise in support of the quality system and product development through project oversight, design and document review, testing, data collection and analysis, problem solving, verification, validation, audit, training, and reporting.
Essential Functions:
-
Contribute to the establishment, operation, and maintenance of the Quality System.
- Development and documentation of quality plans, processes, procedures, and work instructions.
- Perform functional Quality System activities for inspection and test, equipment calibration, nonconforming material, corrective and preventive action, quality records, and statistical techniques.
-
Provide quality support to the product development effort:
- Establish product quality requirements and participate in design reviews.
- Participate in product risk management; hazard analysis and FMEA / FMECA.
- Participate in component, assembly, system, and process verification and validation. Perform process capability analysis.
- Participate in supplier selection, audit, and oversight.
-
Provide quality support for marketed products
- Establish and maintain product quality measures, monitor product reliability, and contribute to improvements.
- Support inspection and test activities as required
- Perform product failure investigations and facilitate required corrective / preventive action
- Produce reports on all activities as required
Other Functional Responsibilities:
- Stay up-to-date on and comply with procedures related to the job that can affect the quality of products or services provided to Company customers and assist in maintenance of favorable company regulatory compliance status.
- Serve as a resource for quality requirements.
- Assist in QA department training programs for Company personnel.
- Perform other related tasks as required.
Skills and Knowledge:
Quality system principles» FDA Quality System Regulation (cGMP)» ISO 9001 / 13485 quality system standards» requirements for product development in a regulated environment, including design control, hazard analysis, validation, and process metrics. Ability to work with development engineers and other functional group personnel to accomplish common goals. Detail oriented, with good written and verbal English communication skills. Computer literate in word processing, spreadsheets, data bases, and other quality related productivity programs. Application of statistical techniques for quality assurance.
Education / Training:
Requires BS / BA in an engineering, technical, or science field. Specific knowledge of quality assurance principles, product development, and manufacturing processes. ASQ Certification - CQE, desired.
Experience:
Requires 5-10 years QA / QC engineering experience in a product development and manufacturing environment, preferably with medical device products.
|
|
|
|
