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New · posted Oct 15

Cook Medical · Medical Devices

Quality and Regulatory Specialist

  • Poway, CA
  • Hybrid
  • Full-time
  • Associate & Specialist
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Pay$79K–$87Ka year · $38.00–$42.00 an hour
EmploymentFull-time
LocationPoway, CAHybrid
LevelAssociate & Specialist
FunctionQuality AssuranceQuality
Deadline

Closes Sep 28, 2027 · 348 days left

The role

K-Tube Technologies manufactures made to order miniature stainless steel tubing for use in medical, automotive, aerospace, and industrial applications. Under limited supervision, the Quality and Regulatory Specialist manages assigned quality system processes and supports K-Tube's Quality Management System through customer complaints, corrective actions, regulatory and compliance requests, audits, return authorizations, calibration, and related quality activities. The role works closely with internal departments, customers, suppliers, and auditors to determine appropriate handling of quality matters, coordinate and prioritize assigned activities, drive quality activities through completion, and identify issues requiring escalation. Through these responsibilities, the position develops the technical knowledge and experience needed to support and back up selected Quality Engineer responsibilities.

Personal Protective Equipment

  • 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 three days per week in the office and additional days as necessary

Status: Full Time/Non Exempt

Reports to: Quality and Regulatory Engineering Manager

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 position.

What you need

  • Associate degree in Quality, Engineering Technology, Manufacturing Technology, Industrial Technology, Science, or a related field required. Relevant manufacturing quality experience may be considered in place of the degree
  • Minimum 3 years experience in a Manufacturing or Quality environment.

Job Knowledge, Skills and Abilities

  • Working knowledge of quality systems and quality principles.
  • General understanding of customer complaints, CAPA, root cause investigation, auditing, document control, calibration, and validation.
  • Approachable, inquisitive, and relates well to all kinds of people.
  • Must have good communication skills, both written and spoken.
  • Must be proficient with MS Word, Excel, Power Point, Outlook
  • Ability to thrive in a fast paced environment, managing multiple projects and assignments simultaneously.

Physical Requirements

  • Must be able to lift to 10 pounds
  • Light physical effort required
  • Regularly required to sit or stand, reach and move about the facility

Skills named in this posting

What you'll do

Customer Complaints, Corrective Actions, and RA’s

  1. Reviews customer complaints and RA requests to determine appropriate handling and escalation, communicates with customers and internal stakeholders, and coordinates complaint activities through closure.
  2. Coordinates investigations, corrective actions, responses, and supporting documentation; tracks progress, commitments, and due dates to support timely resolution.
  3. Supports root cause investigations and continuous improvement activities.

Customer and Regulatory Support

  1. Reviews customer surveys, quality agreements, and regulatory requests to determine appropriate handling, required information, and escalation needs.
  2. Prepares responses within established guidelines and coordinates input from internal stakeholders to support timely and accurate customer communications.
  3. Coordinates PPAPs, first article documentation, certifications, and related customer submissions.
  4. Maintains and reviews customer quality and regulatory records to support compliance and customer requirements.

Quality Systems and Audits

  1. Coordinates Quality Management System review activities, including management reviews and quality meetings, gathers information from multiple departments, and tracks action items and commitments through completion.
  2. Maintains controlled quality records and coordinates document review and approval activities.
  3. Coordinates internal, customer, and certification audits, reviews supporting documentation, works with process owners to address audit requests, and tracks findings and corrective actions through closure.
  4. Schedules, coordinates and documents calibration activities with internal and external parties, reviews calibration status, and tracks overdue activities to ensure equipment remains in calibration.

Quality Engineering Support

  1. Supports validation, investigation, risk assessment, and quality improvement projects.
  2. Reviews drawings, specifications, and quality data to support assigned activities.
  3. Develops technical expertise in K-Tube products, materials, manufacturing processes, and quality systems.
  4. Provides backup support for designated Quality Engineer responsibilities as experience and training permit.

Inspection Support

  1. Provides backup inspection support during absences, workload fluctuations, or investigations.
  2. Maintains working knowledge of inspection methods and quality requirements.

Pay

$79,040 – $87,360 a year

Employer provided

$38.00 – $42.00 an hour · yearly at 2,080 hours (40 a week)

How this compares

Pay Range: $38.00 - $42.00 per hour

Where you'll work

Poway, CAHybridOpen in Maps (opens in a new tab)

More jobs in Poway, CA

Working conditions

  • Work performed in both a manufacturing and office environment
  • Minimal exposure to metals, lubricants, solvents, electrolytes and other hazardous materials
  • Professional environment requiring business casual attire

Job intelligence

The context around this role

Live data · October 15, 2026

Salary intelligence

How the pay compares

This role's midpoint is 6% above the US median for Quality Assurance roles at this level.

This roleEmployer provided

$79,040 to $87,360 a year

Associate & Specialist roles in California31 roles publishing pay

Middle half $77,000 to $96,500, median $80,000

Associate & Specialist roles in the US157 roles publishing pay

Middle half $59,000 to $94,000, median $78,500
Annual base pay
Annual base payLowMedianHigh
This role$79,040—$87,360
California$77,000$80,000$96,500
All US$59,000$78,500$94,000

This role: Cook Medical's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Cook Medical's own promotion track.

  1. This role

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $79K median227 open

  2. Next step

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $123K median353 open

  3. Later

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $153K median136 open

  4. Later

    Director

    Often: Director, Quality · Associate Director, Clinical Quality Assurance

    $209K median114 open

  5. Later

    VP & Executive

    Often: Vice President, Quality Assurance · AVP

    $302K median15 open

Career resources on Quality Assurance

Skills DNA

What this role leans on

How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 6 linesLab testing and methods: 1 lineDocumentation and SOPs: 8 linesInvestigations and CAPA: 7 linesValidation and qualification: 2 linesRegulatory submissions: 1 lineQuality systems and risk: 6 linesData and digital systems: 1 lineCollaboration and leadership: 5 linesGMPLab testingDocumentationInvestigationsValidationSubmissionsQuality systemsData systemsTeamwork
  • Documentation and SOPs8
  • Investigations and CAPA7
  • GMP and compliance6
  • Quality systems and risk6
  • Collaboration and leadership5
  • Validation and qualification2
  • Lab testing and methods1
  • Regulatory submissions1
  • Data and digital systems1

Company hiring pulse

Cook Medical on Regulatory Jobs

7
Open roles
6
Distinct roles
4
Locations

By discipline

  • Quality6 86%
  • Regulatory1 14%

By level

  • Senior & Principal4 57%
  • Associate & Specialist3 43%
See all 7 Cook Medical roles

More roles at Cook Medical

All 7 Cook Medical roles

Similar Quality Assurance roles elsewhere

Quality and Regulatory Specialist at Cook Medical

Applications close September 28. $79K–$87K a year, employer provided.

Job alerts
    Quality and Regulatory Specialist at Cook Medical — Poway, CA | Regulatory Jobs