Job Summary:
The Supplier Quality Engineer is responsible for ensuring high quality product is received from Highridge Medical's suppliers. This is accomplished through performing supplier qualifications, monitoring supplier performance, and maintaining a good working relationship with suppliers that will advance quality improvements and appropriate supplier corrective actions.
Principal Duties and Responsibilities:
- Perform supplier qualification and requalification activities.
- Review supplier change requests and work with supplier to implement approved changes
- Create, implement, and maintain inspection criteria for Receiving Inspection areas.
- Write and run TMVs - Test Method Validations related to receiving inspection activities.
- Review rejections of batches received from suppliers to determine the impact on the product.
- Manage supplier non-conformities, according to internal procedures.
- Manage deviations issued by suppliers and deviations detected in Receiving Inspection.
- Provide data for KPI - Key Performance Indicator and Monthly Trending Reports of supplier-related activities.
- Drive all supplier quality related activities for the transfer of production to new or existing suppliers.
- Manage CAPA –Corrective and Preventive Actions, derived from supplier non-conformities.
- Manage SCARs - Supplier Corrective Action Report, issuance corrective actions, communication, review, and closure of suppliers.
- Lead/participate in the performance of supplier audits and internal QMS - Quality Management System audits.
- Manage changes in suppliers through SCN - Supplier Change Notification
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the essential functions for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities)
- Excellent Interpersonal and Communication skills
- Knowledge of quality system requirements
- Formal training and experience in medical device and tissue auditing preferred
- Demonstrated skill in root cause analysis and corrective action implementation
- Understanding of statistics including sampling plans, design of experiments, and process capability
- Understanding of Medical Device regulations (e.g 820 CFR, EU MDR, ISO 13485, etc)
- Excellent oral, writing, and presentation skills
- Excellent analytical and problem solving skills
- Basic computer skills including Microsoft applications, and database management
- Engineering background including expertise in production environment in the medical device field preferred
- Understanding of continuous improvement methodologies including lean, six sigma, and validation
Education/Experience Requirements
- B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE).
- 1-2 years' experience in a similar position
- Combination of education and experience may be considered (in evaluating experience relative to requirements)
Travel Requirements
Up to 20%