• Quality Engineer

    Cook Medical (Poway, CA)


    Overview

     

    Independently performs all types of quality engineering assignments (CAPA completion and review, Complaints, Internal Audit, GR&R, CDR’s, Supplier Control, N/C Containment, Test Method Validation, Quality related Equipment Validation items, product compliance) with detailed plans and timelines. Investigates QC processes to resolve inspection and quality problems through process and documentation updates. Resolves quality equipment issues, with help from outside vendors and suppliers as necessary.

     

    Operates with a high level of autonomy and is trusted to make decisions and take action with minimal oversight. Provides technical guidance to colleagues and supports cross-functional teams.

     

    Pay Range:$91,000 - 100,000/yr

    Responsibilities

    General

     

    + Completes comprehensive responses for customer complaints, including during audits, customer tours, product discussions.

    + Authority to stop production or to limit further processing of nonconforming product until the deficiency has been corrected.

    + Participates in monthly reviews and reports on assigned key processes.

    + Identifies and supports opportunities for business process improvements.

     

    Quality Systems

     

    + Key contributor to Quality Systems at K-Tube including nonconformance systems, deviation requests, complaints, corrective action systems, document control systems and supplier audits; including the initiation of actions to meet objectives.

    + Key contributor to Test Method and Equipment Validation, including drafting and completion of relevant validation documentation.

    + Reviews and responds to product compliance questionnaire and surveys.

    + Execute supplier quality activities.

    + Executes customer product qualifications as requested.

    + Reviews changes and generates Process Change Notifications for customers.

    + Serves as an Internal Audit Team member as assigned.

    + Troubleshoots quality control equipment as required.

     

    Teamwork and Change Management

     

    + Interacts and communicates with associated operating departments as necessary to produce cohesive efforts towards accomplishing Company goals. Reinforces an environment of teamwork and collaboration.

    + Acts as a contributing member and occasional lead in cross-functional teams and change initiatives

    + Builds strong working relationships across functions and levels

    + Serves as a liaison between engineering, production, and quality

    Qualifications

    Education and Experience:

    + Bachelor’s degree in Industrial, Mechanical, Manufacturing, Electrical, or Quality Engineering; other STEM fields may be considered based on experience

    + Minimum 4 years of experience in a Quality Engineering or similar role within a manufacturing environment

    + Hands-on experience with ISO 9001 quality systems, including auditing, implementation, and process maintenance

    + Certified Quality Engineer (CQE) through ASQ preferred

    Job Knowledge, Skills and Abilities:

    + Strong foundation in engineering principles and problem-solving

    + Familiarity with statistical quality methods (SPC, capability studies, etc.) preferred

    + Demonstrated ability to be an effective team member within a cross-functional team

    + Approachable, inquisitive, and relates well to a diverse set of people.

    + Excellent analytical skills; able to identify root causes and recommend practical solutions

    + Strong written and verbal communication skills

    + Proficient in Microsoft Word, Excel, and PowerPoint

    Physical Requirements:

    + Must be able to lift up to 25 pounds

    + Light to moderate physical effort required

    + Regularly required to sit or stand, reach and move about the facility

     

    Work environment

     

    + Work performed in both a manufacturing and office environment

    + Exposure to metals, lubricants, solvents, electrolytes and other hazardous materials

    + Requires some travel

     

    Personal Protective Equipment

     

    + Safety glasses and safety shoes are required

    + Other personal safety equipment required as listed in SDS depending on task may include safety goggles, ear protection, full - face shield, apron, arm guards, rubber boots and gloves

     

    Position Type: Hybrid – typically requires 3 days per week in the office and additional days as necessary

     

    Reports to: Quality and Regulatory Engineering Manager

    We offer US based employees:

    + Competitive base and bonus

    + Medical, dental, and vision insurance

    + 401(k) plan with ER match - 100% on first 4% contributed, profit sharing plan with 6 year vesting schedule

    + 15 days of PTO

    + 8 paid holidays

    + Office closure between December 23 - January 1

    + 5 paid sick days

    + Paid parental leave

    + Tuition Assistance

     

    Qualified candidates must be legally authorized to be employed in the United States. K-Tube does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

     

    We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.

     

    Requisition ID2025-17003

     

    Posting Date4 days ago(7/29/2025 3:08 AM)

     

    Job Location(s)Poway CA United States

     

    Job LocationsUS-CA-Poway

     

    TravelNone

     

    Position TypeFull Time

     

    CompanyK-Tube Corporation

     

    CategoryQuality