Quality Engineer

2 months ago

Ontario, United States Stevanato Group Full time

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

  • Quality Control Supervisor

    1 month ago

    Ontario, United States Stevanato Group Full time

    ***Position will oversee 3 shifts in a 24/7 working facility***1st - 6:00 am to 2:30 pm2nd - 2:00pm to 10:30 pm3rd - 10:00 pm to 6:30 amJob Summary:The primary purpose of the Quality Control Supervisor is to coordinate activities and provide daily direction to quality team members to ensure that quality requirements, performance goals and improvement...

  • Quality Assurance Manager

    4 weeks ago

    Ontario, California, United States Datwyler Full time

    At Datwyler, we're committed to delivering high-quality elastomer components that make a difference in the lives of patients and drivers worldwide.As a Quality Assurance Manager, you'll play a critical role in ensuring our products meet the highest standards of quality, safety, and reliability.Key Responsibilities:Maintain and improve our quality management...

  • Quality Operations Lead

    4 weeks ago

    Ontario, California, United States STERIS Full time

    Job SummaryThe Quality Operations Lead is responsible for the execution of the quality management system by managing processes, leading projects, and directing associates to maintain and improve the quality system in accordance with regulatory standards. This role requires a strong understanding of quality management systems, including ISO 9001, ISO 13485,...

  • Quality Assurance Manager

    4 weeks ago

    Ontario, United States Datwyler Full time

    At Datwyler, we are committed to delivering high-quality, system-critical elastomer components that meet the stringent requirements of our customers.The Quality Manager will play a crucial role in maintaining and improving our quality management system, ensuring compliance with AS9100, ISO 9000, and NADCAP requirements.Key Responsibilities:Maintain and...

  • Quality Assurance Manager

    1 month ago

    Ontario, California, United States Vishay Intertechnology Inc Full time

    Vishay Intertechnology Inc. is seeking a Quality Assurance Manager to develop, maintain, and implement company quality policies, processes, and systems. The ideal candidate will have a strong understanding of ISO 9001:2015 quality management system standard and be able to manage Receiving Inspectors, Final inspectors, and Quality Engineers.The Quality...

  • Project Engineering Lead

    2 weeks ago

    Ontario, United States Tiercon Full time

    Company Overview: Tiercon Corp. is an automotive supplier committed to the design, manufacture and assembly of quality exterior trim and assembled systems used as original equipment in the automotive market. Headquartered in Stoney Creek, the plants have design, mold, paint, assembly and testing capabilities. Tiercon manages 5 sites across 2 cities employing...

  • Senior Electrical Engineer

    1 month ago

    Ontario, California, United States Tech USA Full time

    Job OverviewAt Tech USA, we are seeking a highly skilled and experienced Senior Electrical Engineer to join our team. This is a key leadership role that requires a strong technical background and excellent communication skills.Key ResponsibilitiesLead the design and development of electrical systems for large and complex projects.Collaborate with...

  • Quality Assurance Specialist

    4 weeks ago

    Ontario, United States STERIS Full time

    Job SummaryThe Quality Assurance Specialist will assist in the administration of the quality management system at a site to ensure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role will lead complaint/CAPA investigations, supplier quality improvement...

  • Structural Engineer Position

    4 weeks ago

    Ontario, United States Meridia Recruitment Solutions Full time

    We are seeking a highly skilled Structural Engineer to join our team at Meridia Recruitment Solutions. The ideal candidate will have a strong background in structural design and a proven track record of delivering high-quality projects.The successful candidate will be responsible for planning, designing, and preparing engineering drawings and documentation...

  • Senior Process Engineer

    4 weeks ago

    Ontario, United States Elite Comfort Solutions LLC Full time

    We are seeking a highly skilled Senior Process Engineer to join our team at Elite Comfort Solutions LLC.The ideal candidate will have a strong background in manufacturing and production engineering principles, concepts, and general business operations.Responsibilities will include developing and evaluating new processes, improving current process capability,...

  • Civil Project Engineer

    4 weeks ago

    Ontario, California, United States HNTB Full time

    Job SummaryWe are seeking a highly skilled Civil Project Engineer to join our team at HNTB. As a key member of our engineering group, you will be responsible for delivering high-quality projects that meet the needs of our clients.Key ResponsibilitiesDevelop and implement design calculations, technical reports, and engineering plans and specifications for...

  • Senior Engineering Manager

    2 weeks ago

    Ontario, United States HNTB Full time

    Job OverviewWe are seeking an experienced professional to fill the role of Senior Resident Engineer/Construction Manager. This position involves overseeing large-scale projects and ensuring that they are completed on time, within budget, and to the required quality standards.Key ResponsibilitiesProject Management: Coordinate project activities, establish...

  • Lead Quality Operations Manager

    4 weeks ago

    Ontario, California, United States STERIS Full time

    Position SummaryThe Lead, Quality Operations is responsible for the execution of the quality management system by managing processes, leading projects, and directing associates to maintain and improve the quality system in accordance with regulatory standards. This role requires strong leadership and technical skills to ensure compliance with ISO 9001, ISO...

  • Marine Structural Engineer

    4 weeks ago

    Ontario, United States Moffatt & Nichol Full time

    Job Summary:Moffatt & Nichol is seeking a highly skilled Marine Structural Engineer to join our team. As a key member of our engineering team, you will be responsible for designing and analyzing waterfront structures, including piers, wharves, bulkheads, and marinas. You will work closely with senior engineers and managers to deliver high-quality engineering...

  • Packaging Solutions Engineer

    1 month ago

    Ontario, California, United States Ajinomoto Foods North America Full time

    Job SummaryWe are seeking a highly skilled Packaging Solutions Engineer to join our team at Ajinomoto Foods North America. The successful candidate will be responsible for delivering innovative packaging solutions that meet marketing requirements and consumer insights.Key ResponsibilitiesDevelop and implement packaging solutions for flexible films,...

  • Production Manager

    3 weeks ago

    Ontario, United States ENTEGRA Full time

    Job Type Full-timeDescriptionPosition Summary: We are seeking an experienced and driven Production Manager to lead our engineering department in the production of both mechanical and electronic components. This role involves overseeing the manufacture and in-house assembly of our custom pipeline inspection tools, ensuring high standards of quality,...

  • Packaging Engineer II

    3 months ago

    Ontario, United States Ajinomoto Foods North America Full time

    Overview The primary role of this position is to deliver innovative packaging solutions based on marketing requirements, consumer insights, and AFNA's objectives of improving cost competitiveness and sustainability. This position will also support existing businesses through packaging revisions, cost savings projects, and packaging harmonization projects....

  • Applications Engineer

    1 week ago

    Ontario, United States Maury Microwave Full time

    Job Title: Applications Engineer FLSA Status: Salaried Exempt Department: Engineering Reports to (Title): Applications Manager Brief Summary of Position: Uses technical knowledge of microwave theory to understand customer measurement and characterization challenges. Provides hands-on demonstrations with MMC device characterization systems to show solutions....

  • Applications Engineer

    2 months ago

    Ontario, United States Maury Microwave Corporation Full time

    Job DescriptionJob DescriptionJob Title: Applications EngineerFLSA Status: Salaried ExemptDepartment: EngineeringReports to (Title): Applications ManagerBrief Summary of Position:Uses technical knowledge of microwave theory to understand customer measurement and characterization challenges. Provides hands-on demonstrations with MMC device characterization...

  • Packaging Solutions Engineer

    4 weeks ago

    Ontario, California, United States Ajinomoto Foods North America, Inc. Full time

    Packaging Solutions EngineerUS-CA-OntarioJob ID: Type: Regular Full-Time# of Openings: 1Category: Research & DevelopmentOntario (Corporate Office)Overview The primary role of this position is to deliver innovative packaging solutions based on marketing requirements, consumer insights, and AFNA's objectives of improving cost competitiveness and...