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PDS Tech Inc Staff QA Engineer in Rochester, New York

PDS Tech is seeking candidates for a QA Engineer position in Rochester, NY

Position Summary:

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.

Responsibilities :

  • 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

Minimum Requirements/Qualifications

  • 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.

Professional Characteristics:

  • 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.