Jobs
>
Irvine

    Manager - Quality Assurance Engineering - Irvine, United States - Prismatik

    Prismatik
    Prismatik Irvine, United States

    3 weeks ago

    Default job background
    Description


    Position at Prismatik

    Essential Functions:
    • Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects.
    • Hires, manages, trains, develops, reviews, and set goals for department and staff.
    • Acts as both coach and mentor to team members in areas of problem solving, decision-making, and process improvement.
    • Addresses all employee relations matters in a timely manner in coordination with Human Resources.
    • Manages and ensures staff's adherence to Company policies and procedures.
    • Manages, modifies, and maintains a complete and comprehensive quality system to support development and contract manufacturing of medical products.
    • Oversees the technical side of the Company's quality system and processes in relation to new product development and process improvement projects.
    • Oversees the implementation of new products against market and technical standards.
    • Evaluates the product manufacturing process and systems to ensure quality standards and timely and efficient flow of assigned projects.
    • Implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
    • Participates in the reviewing of engineering designs to contribute quality requirements and considerations and supports areas in gathering and analyzing data.
    • Develops product/organizational quality assurance strategies including new European standards (MDSAP) where applicable.
    • Develops and analyzes reports related to department metrics. Prepares and presents organizational performance and technical information to the management team and associates.
    • Refines and implements quality product process plans and systems.
    • Develops and reviews standard operating procedures (SOPs) and other required policies.
    • Serves as quality engineering subject matter expert.
    • Serves as the quality representative on new product introduction teams.
    • Assures validation and compliance of contract manufacturing and sterilization facilities.
    • Manages Quality Engineering activities.
    • Organizes procedures and documentation related to areas of responsibility.
    • Participates in internal, external, and third party audits.
    • Provides technical assistance to other functional areas regarding interpretation of specifications, regulations, material qualifications, first article evaluations, and other quality related subjects to increase understanding of SOPs and guidance documentation.
    • Performs other related duties and projects as business needs require at direction of management.
    Minimum Qualifications:
    • Bachelor's degree in a related engineering discipline.
    • Minimum seven (7) years of related quality assurance experience.
    • Previous management and leadership experience.
    • Advance knowledge with development and test requirements with recognized standards (ISO
    • Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach.
    • Demonstrated knowledge and understanding on regulations and guidance as related to software development, SaMD.
    • Demonstrated ability to implement and improve Software QMS processes.
    • Demonstrate knowledge of group software development methods (Agile Process and Scrum Method).
    Pay range: $112,000-$155,000/yr

    Exact compensation may vary based on skills and experience.

    Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell

    In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more

    Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.

    Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.
  • Glidewell

    Sr. Quality Assurance Engineer

    3 weeks ago

    Glidewell Irvine, United States

    Description · Position at Prismatik Essential Functions : · Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medic ...

  • PRISMATIK DENTALCRAFT, INC.

    Quality Assurance Engineering Manager

    4 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell · Essential Functions: · Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects. · Hires, manages, trains, develo ...

  • PRISMATIK DENTALCRAFT, INC.

    Sr. Quality Assurance Engineer

    3 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell · Essential Functions: · Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and e ...

  • PRISMATIK DENTALCRAFT, INC.

    Senior Quality Assurance Engineer

    3 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Prismatik Dentalcraft is a Glidewell Dental company. · Essential Functions: · Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal an ...

  • Integra LifeSciences

    Manager, Design Assurance/Reliability Engineering

    4 weeks ago

    Integra LifeSciences Irvine, United States

    Changing lives. Building Careers. · Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging whats poss ...

  • Motion Recruitment Partners, LLC

    DOD Assurance Engineer

    2 weeks ago

    Motion Recruitment Partners, LLC Irvine, United States

    An international medical device company is looking to bring on a Product Security Engineer to join their team. You'll work on embedded hardware of medical devices, hardening them. Ideal candidates have familiarity with NIST RMF SP process and have used tools like OpenSCAP and DIS ...

  • Network Optix

    Quality Assurance Engineer

    1 week ago

    Network Optix Irvine, United States

    Network Optix · (Nx) is a powerhouse in video software development, driven by a mission to empower the creation of intelligent video-based solutions and products capable of converting video into actionable data. Over a decade in the making, the Network Optix Enterprise Video Pla ...

  • Verizon Communications Inc

    Quality Assurance Engineer

    2 weeks ago

    Verizon Communications Inc Irvine, United States

    When you join Verizon · Verizon is one of the world's leading providers of technology and communications services, transforming the way we connect around the world. We're a human network that reaches across the globe and works behind the scenes. We anticipate, lead, and believe ...

  • Motion Recruitment

    DOD Assurance Engineer

    21 hours ago

    Motion Recruitment Irvine, United States CONTRACT

    An international medical device company is looking to bring on a Product Security Engineer to join their team. You'll work on embedded hardware of medical devices, hardening them. Ideal candidates have familiarity with NIST RMF SP process and have used tools like OpenSCAP and DIS ...

  • CoStar Realty Information, Inc.

    - Team Lead, Software Quality Assurance Engineer

    6 hours ago

    CoStar Realty Information, Inc. Irvine, United States

    - Team Lead, Software Quality Assurance Engineer · Job Description · CoStar Group (NASDAQ: CSGP) is a leading global provider of commercial and residential real estate information, analytics, and online marketplaces. Included in the S&P 500 Index and the NASDAQ 100, CoStar Group ...

  • Kerr Corporation

    Design Assurance Engineer

    3 weeks ago

    Kerr Corporation Orange, United States Full time

    Description · : The Design Assurance Engineer is responsible for developing and maintaining test methods, validations, and verification activities for new product development, sustaining, and quality system compliance activities for dental consumables. · Note: This role will be ...

  • ACE Partners

    Software Quality Assurance Engineer

    1 week ago

    ACE Partners Irvine, United States

    A leading medical device organization are seeking a skilled Quality Assurance Software Engineer to join their team on a W2 contract basis. · Duration: 6-9 Months (opportunity to convert FT after this period) · Rate: $ ph DOE (W2). No C2C or 1099 · Location: Irvine, CA (Onsite) · ...

  • PRISMATIK DENTALCRAFT, INC.

    Senior Quality Assurance Engineer

    4 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Prismatik Dentalcraft is a Glidewell Dental company. · Essential Functions: · Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and ...

  • ACE Partners

    Software Quality Assurance Engineer

    1 week ago

    ACE Partners Irvine, United States

    A leading medical device organization are seeking a skilled Quality Assurance Software Engineer to join their team on a W2 contract basis. · Duration: 6-9 Months (opportunity to convert FT after this period) · Rate: $ ph DOE (W2). No C2C or 1099 · Location: Irvine, CA (Onsite) ...

  • PRISMATIK DENTALCRAFT, INC.

    Quality Assurance Engineering Manager

    3 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell · Essential Functions : · Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects. · Hires, manages, trains, deve ...

  • PRISMATIK DENTALCRAFT, INC.

    Quality Assurance Engineering Manager

    3 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell · Essential Functions: · Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects. · Hires, manages, trains, dev ...

  • PRISMATIK DENTALCRAFT, INC.

    Sr. Quality Assurance Engineer

    4 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Essential Functions: · Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices. · Resp ...

  • Financial Statement Services, Inc

    Software Quality Assurance Engineer

    10 hours ago

    Financial Statement Services, Inc Santa Ana, United States

    Job Description · Job DescriptionOpening its doors over 40 years ago, FSSI is one of the largest woman-owned providers of document services in the western United States, specializing in highly-customizable print and mail, electronic delivery, marketing and compliance solutions. A ...

  • CoStar Group

    - Senior Software Quality Assurance Engineer

    2 weeks ago

    CoStar Group Orange County, United States Full time

    Responsibilities · Performs functional, end-to-end, integration, regression, browser and exploratory testing · Ensures that products conform to business requirements/company policies, software quality standards, and established procedures · Validates products against specs, desig ...

  • BioPhase Solutions

    Sr. Quality Assurance Engineer

    2 weeks ago

    BioPhase Solutions Orange County, United States

    Job Description · Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Sr. Quality Assurance Engineer to work for an Orange County area medical device company.Salary: ...