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Quality Engineer II

Company: Viant Medical
Location: Upland
Posted on: June 23, 2022

Job Description:

Come join a growing, steady company! Excellent Benefits and a great team to work with.

  • Full Medical, Dental & Vision, 401(k), effective on your 1st day
  • Paid holidays
  • Growth OpportunitiesAre you passionate about being part of a Team that will become the most trusted medical device molding and assembly service provider? Are you tired of mundane cubicle Quality roles? Join Team Upland as our Quality Manufacturing Engineer II and realize your full potential as a High Impact member of our Quality team.

    PURPOSE: We produce medical devices that save and enhance lives! The primary purpose of our Quality Engineer II position is to apply Quality principles to drive process improvements in the manufacturing of medical devices while positively affecting quality, delivery, cost, safety and moral. We are looking for someone with a positive attitude with excellent attention-to-detail who wants to grow professionally with high internal expectations. As well collaborate with the site while promoting the culture of always meeting or exceeding the expectations of our Customers, with a focus on Continuous Improvement, Operational Excellence, and building a true High Performance Team.

    INNOVATION: Implement Advanced Manufacturing technologies and solutions while flexing your creativity engine. Work with other Viant Medical sites and engineering teams to benchmark successes and share best practices. Drive process improvements utilizing Lean Quality techniques, Root cause analysis and cross functional team building.

    GROWTH: Being a growth site we are looking for individuals that are looking for development. You will be working with our internal and external customers in a highly dynamic work environment that encourages and promotes developmental growth in many areas. Opportunities are available in metrology, New Product development, robotics and driving improvement though operational excellence programs.

    MISSION / VISON: We partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world. Our focus is on enhancing the customer experience by building true business partnerships and our business though, Teamwork, Being Agile, having Personal Integrity, Owning It, and Recognizing the Success of others because together, We Are In It For Life.

    Skills/Competencies
    • Problem Resolution: identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive action
    • Continuous Quality Improvement: systems, documents, software and technical tools.
    • Reporting of internal and external quality problems and trends.
    • Coordinates activities between Engineering, Manufacturing and Quality, including qualification and validation.
    • Monitoring and improvement of SPC systems, sampling plans and statistical methods.
    • Cost of Quality reporting and analysis, as required.
    • Training of personnel to improve technical skills, job knowledge and performance.
    • Planning, controlling, and assuring product and process quality.
    • Back-up and or perform to QS Management//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.
    • Coordinate with other departments as member of problem solving teams.
    • Assist Inspectors in Quality Assurance as needed.
    • Represent Viant with customers, vendors and outside auditors
    • Execute Document Control functions as deemed necessary.
    • Utilize tools, gauges and other inspection equipment to obtain product specification data
    • Work on validation projects along with Customer, Manufacturing Engineering team.
    • Expert with utilizing ANSI Sampling Plans
    • Expert in utilizing hand measurement tools (Caliper, Micrometer, Ruler, Gage Blocks, etc.)
    • High Proficiency with PCDMIS and Measuremind 3D automated inspection software (CMM, OGP, Smart scope, etc.)
    • High Proficiency in material analysis (i.e. FTIR, Melt Flow Testing, etc.)
    • Proficiency with Medical device standards and Regulations (ISO 13485)
    • Ability to read and decipher blueprints
    • Proficient in GD&TRequirements:
      • Minimum Education: Minimum 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.
      • Knowledge & Skills:
      • Expert in utilizing hand measurement tools (Caliper, Micrometer, Ruler, Gage Blocks, etc.). High Proficiency with PCDMIS and Measuremind 3D automated inspection software (CMM, OGP, Smart scope, etc.), IQMS
      • Required - Minimum five (5) years experience in a similar field. Working knowledge in problem solving methodologies. Excellent oral and written communication skills. Preferred - 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
      • 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.
      • Physical Demands: Standing, sitting, walking and lifting. Traveling by car and air.New employees are eligible for the following benefits effective date of hire!
        • Medical, dental, and vision benefits
        • Company-paid life insurance and disability benefits
        • Generous Paid time off and 10 paid Holidays
        • 401k Plan with Company Match
        • Tuition Reimbursement#INDLP

          Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

Keywords: Viant Medical, Upland , Quality Engineer II, Engineering , Upland, California

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