Job ID :
US - New York - Rochester
- Support all Rochester, NY molding departments (Value Streams) to drive product quality continuous improvement to minimize customer complaints
- Through customer complaint data analysis, identify product and process improvement needs.
- Investigate customer complaints.
- Provide timely and accurate communication to customers for complaints and other quality concerns, including writing Corrective Action Responses and closing out completed complaints.
- Engage directly with customers as needed to address concerns and customer complaints
- Follow up to ensure corrective actions for complaints are completed
- Value Streams Support, Corrective and Preventive Action, and other Continuous Improvement Activities
- Provide Quality Support to the Value Streams throughby active participation in meetings, addressing manufacturing issues, and ensuring Non-Conformance Reports are appropriately dispositioned.
- Review customer complaints, non-conformance reports and other metrics to identify CAPA opportunities
- Facilitate CAPA investigations for customer complaints, recurring NCR’s, audit non-conformances, and other investigations using problem solving standard work to identify root cause and implement effective corrective actions
- Participate in PPI (Practical Process Improvement) and projects to support achievement of business metrics (OEE, LIFR, Past Due, Scrap and other cost savings).
- Provide back up support for quality engineers in each Value Stream
- Support Customer Audit Process
- Serve as a backup for hosting on-site customer audits in the absence of the Customer Quality Manager
- Provide support to customer audits with respect to customer complaints and other areas of expertise as requested
- Support Quality Control Inspection (where applicable to customer complaints, and CAPA, and other product quality improvements)
- Ensure the accuracy and adequacy of quality control inspection plans (QCIP’s) and standard test procedures (STP’s) for purchased and manufactured components and finished goods to meet the latest quality and system specifications
- Research, recommend and implement new and improved gauging, measurement and data acquisition systems to improve inspection efficiency and repeatability and reproducibility of measurement systems
- Quality representative on process change and new product / process implementation projects
- Use risk management tools to evaluate impact of change
- Support Engineering on validation protocol development, documentation, and approval (IQ, OQ, PQ) to ensure effectiveness
- Other duties as assigned
- Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience and prior experience in Manufacturing and/or Quality .
- Disciplined problem solving capability: Lean / Six Sigma, Shainin, etc.
- Experience in regulated medical device manufacture with compliance to FDA Quality System Regulation, EU Medical Device Directive and ISO 13485 is a plus.
- Working knowledge of Excel, Word, Access, Minitab, quality software, and statistical methods (SPC, DOE, Gauge R&R etc.) and risk management techniques (dFMEA/pFMEA).
- Project planning and advanced computer skills a plus.
- Plastic product manufacturing experience is a plus.
- Experience working with customers is a plus.
- Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition.
- Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
- Leadership Skills: Proven ability to influence others and lead significant change.
- Strong communication skills both written and verbal