PDS Tech is seeking candidates for a Quality Engineer position in Rochester, NY
Under the direction of the Manager, Quality Assurance Engineering and Quality Control, the Quality Engineer is responsible for assuring manufacturing processes are in compliance with the Comapny's ISO/cGMP Quality Management System to produce consistent quality product. The Process Quality Engineer is also responsible for identifying opportunities and supporting improvement and reduced variation in our manufacturing processes resulting in improved product quality and delivery.
- Drive improved product quality through the use of Quality Assurance principles to drive towards process control.
- Research, recommend, and implement new and improved gauging, measurement, and data acquisition systems to improve inspection efficiency and repeatability and reproducibility of measurement systems.
- 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.
- Communication of QCIP and STP changes to the Quality Control Department in a timely, efficient, and practical manner.
- Serve as the Quality Assurance representative on New Product Development and Sustaining Engineering projects.
- Use risk management tools (such as pFMEAs) to evaluate impact of change.
- Ensure Product Development / Design Control procedures are utilized appropriately to implement new / changes to products and processes.
- Support the Validation of molds, equipment, and processes.
- Determine need for validation of new or changes to molds, equipment, or processes.
- Work with Engineering to develop and document Validation Protocols and Reports (IQ, OQ, PQ) to ensure effectiveness of new or changes to molds, equipment, or processes.
- Review and approve Validation Protocols and Reports (IQ, OQ, and PQ).
- Support Corrective and Preventive Action (CAPA) and other Continuous Improvement Activities.
- Review non-conformance and other manufacturing metrics to identify CAPA opportunities.
- Facilitate CAPA investigations for customer complaints, recurring non-conformances, audit non-conformances, and other investigations using problem solving tools to identify root cause and implement effective corrective actions.
- Analyze process capability data and other quality metrics in order to propose specification or process changes to Engineering.
- Participate in PPI (Practical Process Improvement) projects to support achievement of business metrics (OEE, LIFR, Past Due, Scrap, and other cost savings).
- Other duties as assigned.
- Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience and 5 to 7 years direct Quality Engineering or equivalent experience.
- Disciplined problem solving capability: Lean / Six Sigma, Shainin, and etc.
- Experience in regulated medical device manufacture with compliance to FDA Quality System Regulation with, EU Medical Device Regulation and ISO 13485:2016 is a plus.
- Working knowledge of Excel, Word, Access, Minitab, quality software, and statistical methods (SPC, DOE, Gauge R&R, and etc.) and risk management techniques (dFMEA/pFMEA).
- Project planning and advanced computer skills a plus.
- Plastic product manufacturing experience is plus.
Knowledge, Skills, Abilities
- Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making, and ambition.
- Excellent interpersonal skills that facilitate the ability to build and maintain relationships with internal and external customers 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.