The Lead Quality Assurance Engineer is responsible for the management and compliance of the Quality Assurance function for the company, including:
v Supervision of Quality Assurance Associates.
v Complaint System Management.
v Corrective Action Report/Preventative Action Report System Management.
v Managing the Material Review Board (MRB).
v Overseeing the equipment calibration program.
v Developing new product inspection and testing procedures.
v Developing improved inspection and test methods.
v Managing the sterilization process.
v Keeping the controlled environment areas conforming to required standards.
- Meet with the Quality Manager on a regular basis to review and analyze quality data such as complaints, scrap, defect trends and overall compliance to the Quality System.
- Work closely with the Quality Manager to review to address remarks from internal and external audits.
- Schedule, plan and coordinate/host all regulatory and customer audits under the direction of the Quality Manager and Vice President of Engineering.
- Work with the Leadership Team to represent and contribute information on behalf of the Quality Assurance Team.
- Ensure all Quality Assurance Associates are properly trained for existing and new products.
- Review and organize complaint system.
- Coordinate complaint flow and tracking of trends.
- Organize and manage the Corrective Action /Preventative Action report system.
- Monitor Material Review Board activities and coordinate dispositions.
- Maintain up-to-date calibration for all required measuring equipment and ensure all corresponding documentation is organized and up to date.
- Develop new or improved inspection and test methods to assure maximum quality assurance at the lowest practical cost. Train and certify inspectors.
- Evaluate new customer and product quotes from a Quality Assurance standpoint to assure all requirements are defined as required by QSP-028.
- Work with Manufacturing and Engineering in validation plan generation, execution and approval for all process validation as required by QSP-028.
- Maintain a continual awareness of the cost and effectiveness of all receiving, 1 st article, in-process and final inspections.
- Correlate in-process material defects to receiving inspection effectiveness and upgrade methods, materials or suppliers accordingly.
- Work with Production on the integration of assembler self-inspection and accountability into the overall quality system.
- Initiate customer requested sterilization validation procedures (SVP).
- Assure proper labeling, load size and control over all loads to sterilizers.
- Verify sterility of all loads coming back from sterilizer.
- Assure appropriate paperwork is provided to customers prior to final product release.
- Bachelor’s Degree in Engineering or Technical Degree in an engineering discipline.
- A minimum of 5 years supervising quality assurance in a medical manufacturing environment.
- Thorough working knowledge of cGMP, FDA QSR and ISO 13485 standards.
- Excellent overall understanding of Quality Assurance and Quality Control practices and procedures.
- Experience in cellular manufacturing ( Lean, One-piece flow) preferred.
- Ability to produce highly accurate work, and prioritize responsibilities for multiple projects with strict deadlines.
- Excellent record/documentation management skills.
- Intermediate to advanced skills with Microsoft Office; experience in SPC.
- Excellent verbal and written technical communication skills.
- Ability to work professionally with customers and cross-functionally with internal teams.