Principal Quality Engineer

Great opportunity to work for an amazing company. Our client is looking for a Principal Quality Engineer in Ontario, Ca facility. If you are interested in joining a highly productive, quality focuses team that helps provide life saving products, please apply!

Excellent Benefits
Dental
Medical
Vision
Vacation time

Support the development and manufacturing of medical devices in conformance with applicable US FDA and ISO13485 requirements.
Responsible for quality planning of all new development programs and design transfers to production.
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.
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 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.

Desired candidate will have prior work history in 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, and/or TS 16949 standards.
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