Quality Assurance Engineer - Manufacturing
The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product lifecycles.
- Drive continuous improvement actions focused on product quality.
- Works with Engineering and Manufacturing to develop acceptance criteria for production processes.
- Works with Service and the Complaint Handling Unit to investigate product problems, perform root cause analysis and identify possible corrective actions.
- Analyzes production quality data to identify trends or issues which require action or CAPA activity.
- Assists in creating and implementing procedures in the quality management system.
- Assists in the review and disposition of nonconforming materials.
- Assists in the creation and validation of manufacturing processes.
- Conducts internal audits of production processes and report results.
- Reviews manufacturing process and part deviations.
- Creates quality alerts when acceptance activities need to be adjusted.
- Supports external regulator or customer audits
- Creates and revises, as necessary, acceptance activities instructions.
- Provides response to inquiries related to quality assurance arising from tenders or other sales efforts.
- Performs other duties as requested.
- Bachelor of Science degree in Engineering or related field.
- 3+ years relevant work experience.
- Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971).
- Experience with manufacturing / quality methodologies such as QFD, six-sigma, lean, etc.
- Understanding of statistical analysis techniques and tools.
- Experience with formal quality systems such as ISO 13485 or ISO 9001.
- ASQ or related quality certification is preferred.
- Work experience in a FDA regulated environment is preferred.
- Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.)
- Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc.
- Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems.
- Excellent verbal and written communication skills using the English language.
- Able to coordinate multiple activities and actions of persons contributing to assigned tasks.
- Detail oriented with good organizational and record keeping skills.
- Ability to work independently and as part of a team.
- Proactive and timely in execution of assigned tasks.
- Able to be flexible and adaptable when needs and priorities change