General Information:
- Company: Surefire Medical, Westminster, CO
- Position: Quality Assurance Engineer
- Reports to: VP, Regulatory Affairs and Quality Assurance
- Surefire Medical, Inc., a Westminster, Colorado-based medical device company that develops and manufactures intravascular catheters for use in interventional radiology, is seeking a Quality Assurance Engineer. You must be an experienced quality professional, who is a self-starter and is comfortable in a fast-paced setting.
Responsibilities:
Effectively communicate within all levels of the organization around concepts of process controls/validation; failure investigation and root cause analysis, inspection/test methods, sampling/statistical techniques, corrective and preventive actions, and risk management.
- Process Validation/ Monitoring: Collaborate with Operations Team in process validation and monitoring activities, including IQ/ OQ/ PQ, Test Method Validation. Write product Quality Plans. Implement and monitor product and process quality using statistically based techniques.
- Risk Management: Lead product and process risk assessment activities: FMEA and Risk Management Reports.
- Supplier Quality: Lead supplier qualification activities including conducting supplier audits. Manage the Supplier Performance Program. Interface with suppliers to drive corrective actions.
- Non-Conforming Materials: Manage the non-conforming materials program, including investigation and disposition activities. Communicate quality issues to vendors.
- Customer Complaints: Manage the customer complaint handling process, including performing failure investigations and root cause analysis.
- CAPA: Perform quality data analysis and issue quality trend reports. Manage the CAPA program, including identification of quality issues/trends, perform or lead root cause analysis activities, identify and manage corrective/preventive actions, oversee CAPA implementation and assess effectiveness.
- General: Provide technical leadership and support to the Quality and Engineering teams (e.g. inspection/test activities, calibration, cleanroom certification and monitoring, sterilization validation.) Assist or lead quality system improvement projects. Perform other quality activities and projects as assigned.
Qualifications:
- BS in Engineering, Science, Biomedical or related field of study. CQE certification a plus.
- 5+ years of Quality Assurance Engineering in a medical device company. Experience in the manufacture of sterile disposable products a must. Experience with intravascular devices a plus.
- Knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485), risk management (ISO 14971), biocompatibility (ISO 10993-1), ethylene oxide sterilization (ISO 11135), sterile product packaging (ISO 11607), product microbial monitoring (ISO 11737) and cleanroom monitoring (ISO 14644).
- Knowledge and application of statistical techniques, SPC, DOE, and problem solving tools.
- Adept in use of computer software for the analysis of data, such as Microsoft Excel and Minitab.
- Must possess a strong sense of urgency, teamwork, keen attention to detail, ability to plan, organize and multi-task.
- Excellent communication skills (oral and written).
Apply information
Qualified candidates should forward their resumes with cover letter and salary requirements to info@surefiremedical.com with subject:Job Quality Assurance Engineer
