Responsible for serving as a member of a Cross Function Customer Focus team and assisting the Director of RA/QA in the maintenance of the Quality Management System. Responsible for assuring compliance with Quality System Procedures through the support of QA personnel.
Primary Duties and Responsibilities
- Assist in the development and review of Purchasing Specifications and receiving inspection criteria as new products are brought on line.
- Responsible for gaining a comprehensive understanding of the manufacturing process prior to transfer to manufacturing and for assisting in the transfer to manufacturing through training of QA inspection and manufacturing personnel.
- Develop and maintain verification and inspection procedures, methods, and sampling plans to assure customer requirements and product specifications are met.
- Lead in the development and maintenance of Limit Samples and other inspection aids and training tools
- Lead all Risk Assessment activities (PFMEAs and DFMEAs)
- Lead QA Specialists in the Nonconforming Materials Control Process by assuring non-conformances are investigated, controlled, documented, resolved and closed in a proper and timely manner
- Perform investigations and document findings related to Corrective Action and Preventive Actions that are initiated. Performs follow-up verifications after CAPA Plans are implemented
- Evaluate, summarize and report on quality data and Key Performance Indicators to assure problems are being adequately addressed and there are no indications of trends or system breakdowns.
- Provide support to other Managers and Engineers related to Cost Savings and continuous improvement Initiatives
- Provide interface and communications with customer and suppliers on all quality concerns.
- Develop and maintain training modules and training effectiveness assessments related to quality procedures and practices
- Review and approve Validation Protocols and Reports
- Assist in the execution of Validation activities as required.
- Interfaces with Suppliers regarding incoming quality issues
- Performs Supplier Audits
- Conducts Internal Audits
- Guidance and oversight on non-conforming materials, including re-work
- Other duties as assigned
- 4 year BS degree or equivalent applicable experience
- Proficient in the use of Quality Management Tools
- Proficient in Microsoft Office Suite
- Strong writing skills
- Strong verbal communications skills
- Proficient in interpretation of regulatory requirements and standards
- Strong Analytical skills – Cause and Effect Analysis
- ISO 9001 or ISO 13485 Certified Auditor
- Experience in the performance of Supplier Audits / Evaluation
- Experience in the appropriate selection of Statistical Tools
Environment & Working Conditions
- Lifting – 30 lbs
- Ability to work in a cleanroom environment
- Standing for long periods of time
- Sitting for long periods of time
- Visual – Constant Visual attention