Quality Engineer

Essential Job Functions and Responsibilities

• Support the development and manufacturing of medical devices in conformance with applicable ISO 13485 requirements.
• Responsible for quality planning of all new development programs and design transfers to production.
• Ensure policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
• Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, Engineering, and Operations.
• Collaborate with Program Managers, Process Engineers, and/or Validation Engineers to execute process and equipment qualifications.
• Problem Resolution: identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive action as well as reporting out of Key Metrics.
• Identify opportunities and implement solutions to drive continuous improvement in performance metrics.
• Investigate customer complaints, corrective actions and trending to drive improvements.
• Plan and perform regular audits of quality system and drive system improvements through the Internal Audit and Quality Event Management (CAPA, NCR, Complaint etc.).
• Monitor and improvement of SPC systems, sampling plans and statistical methods.
• Back-up and or perform to Head of Site Quality/Supervisor Representative, as assigned.
• Plan, prepare, and execute Internal Audits, as assigned.
• Participate in Material Review Board and/or Change Control Board as QA representative.
• Utilize tools, gauges and other inspection equipment to obtain product specification data
• Expert in utilizing hand measurement tools (Caliper, Micrometer, Ruler, Gage Blocks, height gage, etc.).
• High Proficiency with PCDMIS inspection software utilizing CMM’s: Brown, Sharpe, Hexagon, Smart scope.
• Expert with utilizing ANSI Sampling Plans, IQMS, Minitab, Excel and Microsoft Word
• High Proficiency in material analysis (i.e. FTIR, Melt Flow Testing, etc.).
• Able to read and decipher blueprints
• Proficient in metrology and calibration.
• Working knowledge of statistical methods for manufacturing.
• Proficient in Geometric Dimensioning and Tolerancing (ANSI Y-14.5)

Requirements

• Minimum Education: five (5) years’ experience in a similar field.
• Minimum Experience: At least two (2) year experience in a supervision and/or management role.
• Demonstrated experience to lead teams and projects.
• Good organizational skills.
• Previous experience in plastic injection molding related environment.
• Comprehensive understanding of ISO 9001, ISO 13485, JPAL MHLW Ordinance 169, and/or FDA QSR regulatory requirements.
• Computer literate with working knowledge of MS Word, Excel, and Access.
• Desired candidate will have prior work history in MSA, SPC, Mini-tab, Infinity, sterilization, & clean room environment.
• Knowledge, Skills, and Abilities: A working knowledge of FDA cGMP, ISO13485 requirements; A working knowledge of medical device manufacturing quality systems; Working knowledge of Statistical Methods used in manufacturing.
• PC-DMIS knowledge a plus.
• Education and/or Experience: 3-7 Years in Quality Engineering in manufacturing and/or quality assurance.
• Training in applicable ISO 9001, ISO 13485.
• Experience using Minitab.
• Proficient in metrology and calibration standards.
• Proficient in Quality Audit concepts.
• FDA quality standards experience a plus.
• Certifications such as ASQ CQE, CQA, CQM.