PDS Tech Inc Staff QA Engineer in Rochester, New York
PDS Tech is seeking candidates for a QA Engineer position in Rochester, NY
Under the direction of the Quality Engineering Manager, the Staff Quality Engineer is responsible for assuring manufacturing processes are in compliance with Company ISO/cGMP Quality Management System to produce consistent quality product. The Staff Quality Engineer is also responsible for identifying opportunities to drive improvement and reduce variation in our manufacturing processes.
Process validation of molds, equipment, and processes
Determine need for validation of new or changes to molds, equipment or processes
Work with Engineering on validation protocol development, documentation, and approval (IQ, OQ, PQ) to ensure effectiveness
Process Validation IQ, OQ, PQ close-out review, justification, and approval
Corrective and Preventive Action
Review non-conformance and other manufacturing 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 Team to support continuous improvement
Analyze process capability data and other quality metrics in order to propose specification or process changes to Engineering
Quality representative on new product development and capacity expansion projects
Use risk management tools (pFMEA) to evaluate impact of change
Ensure product verification and process validation requirements are reviewed and defined appropriately
Support Quality Control inspection
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 additions and changes to Quality Control Department in a timely, efficient and practical manner
Research, recommend and implement new and improved gauging, measurement and data acquisition systems to improve inspection efficiency and repeatability and reproducibility of measurement systems
Other duties as assigned
Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience, and 7 to 10 years direct Quality Engineering experience.
Lean / Six Sigma experience, Black Belt is a plus.
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, 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 required.
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
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.