Quality Engineer supports all aspects of the Quality Management System, Product Realization and Manufacturing Process Controls. Working with cross functional partners, defines and generates quality control plans, production process controls and procedures. Leads and supports validations including statistical analysis. Engages with customers to address quality issues and define acceptance criteria/attributes.

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.) Monitoring 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.) Ability 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. Working knowledge in problem solving methodologies. Excellent oral and written communication skills.

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. Demonstrated experience to lead teams and projects. Good organizational skills. Previous experience in plastic injection molding related environment. Working in a medical device or other FDA regulated industry. 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 c

GMP, 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

Warehouse areas (limited) Will be required to perform other duties as requested, directed or assigned.