Quality Engineer - Lake Elsinore - POLYMER CONCEPTS TECHNOLOGIES INC.

    POLYMER CONCEPTS TECHNOLOGIES INC.
    POLYMER CONCEPTS TECHNOLOGIES INC. Lake Elsinore

    20 hours ago

    $80,000 - $145,000 (USD) per year *
    Description
    Quality Engineer

    Job Summary

    Provides quality engineering and hands-on quality support to ensure inspections, validation activities, nonconformances, and quality records are effective, compliant, and completed on time across the Apple Valley and Ontario manufacturing facilities. Supports receiving, in-process, first piece, final inspection, and AS9102 First Article Inspection (FAIR) activities as needed. Supports calibration and document control interfaces, technical contract review, IQ/OQ/PQ validation, RCCA, NC and CAPA management, MRB activities, and quality performance reporting. Ensures compliance with AS9100 and ISO 9001 standards while performing inspection and quality engineering functions as required.

    This position is an individual contributor role with no direct supervisory or personnel management responsibilities.

    Essential Job Functions

    Support day-to-day QC activities and provide hands-on inspection support across receiving, in-process, first piece, final inspection, and AS9102 First Article Inspection (FAIR) activities as needed to support workload, production schedules, or customer requirements across Apple Valley and Ontario facilities.

    Develop and maintain inspection plans and risk-based inspection strategies based on product requirements, process risk, historical performance, and customer or regulatory requirements.

    Prepare, review, and support AS9102 FAIR packages, including dimensional verification, objective evidence collection, and documentation completeness.

    Program, operate, and support calibration of measurement and test equipment, including CMM, optical, laser, and multisensory systems, support calibration system compliance.

    Support document control activities and maintain inspection records, validation files, calibration logs, nonconformance records, CAPA documentation, FAIR packages, and KPI data in a compliant state to support audit readiness.

    Support technical quality review of customer contracts, purchase orders, and flowed-down requirements to identify applicable inspection, validation, documentation, and compliance obligations.

    Support compliance with AS9100 and ISO 9001 through inspection practices, validation activities, documentation discipline, and technical quality awareness.

    Support and/or develop IQ, OQ, and PQ validation activities for equipment, tooling, processes, and process changes, including protocol development, execution support, documentation, and reporting.

    Lead and support Root Cause and Corrective Action (RCCA) activities and manage assigned Nonconformances (NCs) and CAPAs from initiation through investigation, corrective action implementation, verification of effectiveness, and closure.

    Support Material Review Board (MRB) activities through technical evaluation, data analysis, risk assessment, documentation, and disposition support.

    Serve as a technical interface for customer quality issues and complaints, including investigation support, data analysis, corrective action development, and preparation of technical responses in coordination with Quality Management.

    Analyze inspection, quality, and process data to identify trends and systemic risks; recommend and support corrective and preventive actions.

    Develop, maintain, analyze, and report quality KPIs, and provide trend analysis and data-driven insights to Quality Management and cross-functional teams to support continuous improvement and Management Review.

    Support customer portal submissions related to inspection data, FAIRs, validations, NCs, CAPAs, KPI reporting, and customer complaint responses.

    Support internal and external audits by preparing objective evidence, explaining technical decisions, and supporting corrective action responses.

    Perform advanced inspection and quality engineering activities, including AS9102 FAIR, APQP, PPAP, and programming of CMM / Optical / Laser systems, as required.

    Provide technical input and support for quality and inspection training, including development or review of training materials related to inspection methods, measurement systems, FAIR, validation, and quality system requirements.

    Additional Duties

    Spreadsheets and dashboards for quality and inspection data

    Customer portals and quality reporting tools

    Calibration management system support and standard inspection activities

    Equipment and software consistent with inspection and quality engineering responsibilities

    Employees may be required to perform other related duties as assigned to meet business needs

    Key Performance Indicators (KPI's)

    Timely processing of inspection, validation, NC, CAPA, FAIR, and quality documentation

    Inspection and quality record accuracy 99%

    Calibration past-due items = 0 (for assigned systems and equipment)

    Nonconformances documented within 24 hours; CAPA effectiveness and closure within defined targets

    Audit readiness no major findings related to inspection, validation, documentation, NCs, CAPA, FAIR, or calibration support

    Effective KPI reporting and trend analysis supporting continuous improvement and management review

    Minimum Qualifications

    High school diploma or equivalent required

    Bachelor's degree strongly preferred in Engineering, Quality, Materials Science, Manufacturing, or a related technical discipline (or equivalent combination of education and directly applicable experience)

    Strong mechanical drawing interpretation, GD&T, and metrology fundamentals

    Proficiency with Microsoft Excel and standard reporting/documentation tools

    5+ years of experience in manufacturing and/or quality, operating in a technical, hands-on capacity consistent with the essential job functions (e.g., metrology systems, AS9102 FAIR, IQ/OQ/PQ validation, RCCA, NC/CAPA, MRB support, KPI reporting, QMS documentation)

    OR

    3+ years of experience with direct exposure to plastic compression molding and/or precision plastic machining and seal applications, including dimensional verification, process/validation support, and structured problem-solving (RCCA/CAP

    Accountability for assigned quality engineering responsibilities

    Knowledge, Skills, and Abilities

    Inspection planning and execution

    AS9102 First Article Inspection (FAIR) preparation and review

    GD&T application and interpretation

    Customer and quality portal usage

    Calibration system awareness

    IQ / OQ / PQ validation support

    Root Cause and Corrective Action (RCCA) facilitation

    Nonconformance, CAPA, and MRB processes

    QMS compliance (AS9100 / ISO 9001

    Clear and effective communication of quality requirements and findings

    Organization and prioritization of multiple quality and inspection tasks

    Analytical, data-driven problem solving

    Physical Requirements

    Ability to stand and walk for extended periods during inspections and testing

    Occasional lifting of materials or equipment up to 50 lbs.

    Frequent use of hands and arms to operate precision measurement instruments

    Work performed in laboratory and production floor environments

    Regular use of required PPE (safety glasses, gloves, lab coats, etc.)

    Possible exposure to chemicals, solvents, polymers, and other materials handled per SDS

    May require occasional off-shift, weekend, or inter-facility support to meet customer or production needs

    Reasonable accommodation may be made to enable individuals with disabilities to perform essential job functions

    Work Environment

    Manufacturing and production environments with exposure to machinery, equipment, and moderate noise levels

    Frequent interaction with cross-functional teams on the production floor at Apple Valley and Ontario facilities

    Required use of PPE in designated areas

    Occasional overtime or travel between facilities based on production and customer needs

    The work environment characteristics described are representative of those encountered while performing essential job functions

    Technical collaboration across operations, engineering, and quality teams

    The work environment characteristics described are representative of those encountered while performing essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform this function.

    Export Control / ITAR Compliance Statement (if applicable)

    This position may require access to information and items subject to U.S. export control laws and regulations, including the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR). Access to such information is restricted to U.S. persons as defined under applicable law. Employment in this position is contingent upon the candidate's ability to comply with U.S. export control requirements and, where applicable, the company's ability to obtain any required authorization.

    Equal Employment Opportunity Statement

    Polymer Concepts Technologies PBY, Inc. is an Equal Opportunity Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status under applicable law.

    This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required. Employees may be required to perform other related duties as assigned, consistent with business needs.

    Compensation details: 95000-108000

    PIe93a92466b6d-26289-39782331

    * This salary range is an estimation made by beBee
  • Work in company

    Quality Engineer

    Only for registered members

    We are seeking a detail-oriented and driven Quality Engineer I to join our team. · ...

    Murrieta Full time

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are seeking a detail-oriented and driven Quality Engineer I to join our team. · ...

    Murrieta, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    A leading Medical Device company in Irvine CA is looking for a Quality Engineer to research test the design functionality and maintenance of products equipment systems processes develop quality standards. · Bachelor s degree in engineering required3-7 years of experienceMedical D ...

    Irvine

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    Job Title: Quality Engineer (New Product Development) · We are looking for a Design Assurance / Quality Engineer (NPD & Manufacturing) who will collaborate with a cross-functional design team to develop novel cardiovascular devices/therapies, providing quality leadership and visi ...

    Irvine

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are seeking a dedicated Quality Engineer to join our team.The primary objective of this role is to ensure that our printed circuit board assembly (PCBA) products meet the highest standards of quality and reliability. · ...

    Lake Forest

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    Job summary: We're seeking an experienced Quality Engineer Professional. The ideal candidate will have proven industry experience as a Quality Engineer. Responsibilities: Maintain and Realize AS 9100 procedures and continuous improvement efforts. Provide training as necessary in ...

    Corona

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    The Quality Engineer will manage high reliability military/defense aerospace, medical and commercial contractors and associated supply chains. The engineer must have job knowledge and experience in Printed Circuit Board Assembly, Electro Mechanical, and cable assembly manufacturi ...

    Irvine

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are hiring Quality Engineers of varying experience levels to join our team. Quality Engineers play a critical role in ensuring products, processes, and systems meet internal quality standards and applicable regulatory requirements within a regulated biotechnology environment. ...

    Irvine $80,000 - $110,000 (USD) Full time

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    Perform Quality Engineering activities related to product development and ongoing cleanroom build support. · ...

    Irvine

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are looking for a Design Assurance / Quality Engineer (NPD & Manufacturing) who will collaborate with a cross-functional design team to develop novel cardiovascular devices/therapies, · provide quality leadership and vision throughout the initial product development cycle up t ...

    Irvine

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are looking for a Quality Engineer (Design Control/Risk Management) who will collaborate with a cross-functional design team to develop novel cardiovascular devices/therapies. · In-depth knowledge of Design Control, Risk Management , and related standards. · Knowledge of Quali ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are looking for a Quality Engineer (Medical Devices). Innovation starts from the heart. At our organisation, we put patients first.We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for str ...

    Irvine

    3 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    The Quality Engineer will play a pivotal role in risk management, efficacy, and compliance of medical devices focusing kidney disease.This senior-level position provides opportunities for technical leadership and strategic oversight of post-market activities. · ...

    Irvine

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. · Collaborating with internal and external stakeholders to achieve company objectives. · Leading technical root cause investigations. ...

    Irvine

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    Role Title: Quality Engineer · Role Locations: Irvine, CA · Duration: Contract · Rate:$50-55/hr on W2 · Job Description: · 2+ years in supplier quality, quality systems, or supply chain role in a regulated or manufacturing environment. · Bachelor's degree in Engineering, Quality ...

    Irvine $50 - $55 (USD)

    1 week ago

  • Work in company

    Quality Engineer

    Only for registered members

    For immediate consideration, please apply directly to this job posting AND email me at ayami with the following: · word copy of resume · 2-3 professional references · 4-5 brief bullet points highlighting technical qualifications Job Title: Quality Engineer - NPI · Job Descriptio ...

    Irvine $80,000 - $145,000 (USD) per year

    17 hours ago

  • Work in company

    Quality Engineer

    Only for registered members

    Eleven Recruiting is seeking a Quality Engineer to join the Quality team of one of our leading Space and Defense clients. This role is responsible for ensuring compliance with AS9100, ISO9001, and customer quality requirements, driving continuous improvement initiatives, and supp ...

    Corona $80,000 - $145,000 (USD) per year

    1 week ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are seeking an accomplished Quality Engineer to join our team at Amerit Consulting in Irvine, CA. As a Quality Engineer, you will be responsible for product and service quality evaluation and control. · Familiarity with GLP, GCP, cGMP, · ,Excellent communication and interperso ...

    Irvine

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    +We are seeking an experienced Quality Engineer / Quality Lead (6–10 years) to support the separation of a medical device company from a parent organization and the transition to a stand alone Quality Management System (QMS).+ · ++• 6–10 years of Quality Engineering experience in ...

    Irvine

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are seeking a hands-on Hardware Quality Engineer with experience in aerospace or defense electronics and mechanical manufacturing. · Bachelor's degree in Mechanical, Electrical, or Manufacturing Engineering, or equivalent hands-on experience. · ...

    Santa Ana $75,000 - $90,000 (USD) Full time

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are seeking a dedicated Quality Engineer to join our team.The primary objective of this role is to ensure that our printed circuit board assembly (PCBA) products meet the highest standards of quality and reliability. · ...

    Lake Forest

    1 month ago

Jobs
>
Quality engineer
>
Jobs for Quality engineer in Lake Elsinore