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Implant Direct - Senior Quality Engineer (Westlake Village/Thousand Oaks, CA)

Company: Envista
Location: California City
Posted on: September 19, 2022

Job Description:

Implant Direct is part of Envista's portfolio of dental product and service companies, including more than 30 trusted brands and over 125 years of dental excellence. With over 4.6 million implants placed worldwide, Implant Direct enables dentists to advance their patients' oral health with high-quality dental implant solutions. All implants are manufactured in the USA using only medical-grade titanium alloy, meeting the industry's highest performance and safety standards. We offer a unique portfolio of products and solutions that elevate the performance of your practice through predictable outcomes, greater patient satisfaction, and reduced total costs. We are committed to renewing confidence and changing lives through enhancing patient access. For more information about Implant Direct, visit www.Implantdirect.com

Job Description:

JOB SUMMARY:

The Implant Direct Senior Quality Engineer is responsible for performing a wide range of Quality Engineering activities primarily supporting Sustaining quality engineering and providing back up to NPD and SQE departments. The incumbent for this position will support various engineering duties including, (but not limited to) MRB, NCMRs, vendor qualification and support, design verification and validations, test method validations, process validations, software validations, equipment qualifications IQ/OQ/PQ, and play a crucial part in leading sustaining projects. Hands-on experience as a Sustaining QE is a plus. Furthermore, incumbent for this position needs to ensure that the Risk Management process is followed and supports the management of standards and guidance.

PRIMARY DUTIES & RESPONSIBILTIES:

  • Support Sustaining activities in the Quality department.
  • Program product inspection routines for the automated vision inspection equipment.
  • Work closely with R&D and Manufacturing, to ensure the highest quality products and processes are being developed and deployed.
  • Ensure that process and equipment improvements/upgrades are properly validated, and placed into production so that resulting product can be produced with the required quality and repeatability.
  • Perform/support engineering analysis of the product performance post-market release using quality inputs such as external defect rates, returns, and line rejects, customer feedback, feedback from regulators, and observations from audits/inspections.
  • Provide leadership/support and direction for activities supporting complaint and CAPA investigations; ensure timely completion with all assigned activities.
  • Provide leadership/support and be accountable for support for CAPA's, Health Hazard Evaluations, Field Corrective Actions, Nonconforming Materials processes, and quality systems related responsibilities.
  • Lead/Participate in internal quality audits.
  • Lead/Participate in Risk analysis and management.
  • Deploy and utilize Statistical Process Control (SPC), where applicable.
  • Assist in the development and implementation of final product testing.
  • Perform statistical sampling, as needed, to ensure product quality and process performance.
  • Support the onboarding of new suppliers (supplier audits included)
  • Support MRB and NCMR evaluation, investigation and dispositions.
  • Vendor qualification and support.

    Job Requirements:
    • Bachelor of Science in Engineering or related Engineering field required.
    • 5+ years in Quality Engineering role in product design and development, preferably in a Class II or III medical device environment.
    • Experience in working within an ISO 13485 compliant Quality Management System. Working knowledge of Process Controls and Design Controls within a regulated Quality Management System (CFR 820).
    • Experience with root cause analysis, statistical technique, lean manufacturing, trending, Risk Management, and Six Sigma methodologies.
    • Solid understanding of design control, US FDA QSR, ISO 13485, EU MDD/MDR, MDSAP, CMDCAS, Brazil RD, Australia TGA, Japan PAL, ISO 14971 and other applicable standards and regulations.

      PREFERRED QUALIFICATIONS:
      • Working knowledge of statistics and statistical packages (MiniTab) and design software (Solid Works).
      • Prior project management experience, a plus.
      • Excellent organization & prioritization skills.
      • Cross functional experience with products, engineering processes and manufacturing processes to maintain credibility to communicate and influence change at all levels within the organization.
      • Prior experience as a Sustaining Engineer in a manufacturing organization preferred.

        #LI-SC1

        IND123

        Operating Company:
        Implant Direct

        Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

        Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Keywords: Envista, Lancaster , Implant Direct - Senior Quality Engineer (Westlake Village/Thousand Oaks, CA), Engineering , California City, California

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