Senior Quality Engineer – Medical Devices

Pyramid Consulting, Inc; Los Angeles (CA); Hybrid; USD 83,000 - 87,000; Full time

Job summary

Pyramid Consulting, Inc. has an immediate opening for a Senior Quality Engineer – Medical Devices on a 6+ month contract in Los Angeles, CA.

The role focuses on post-market support, sustaining engineering, and cross-functional collaboration to ensure patient safety and regulatory compliance. The ideal candidate holds a Bachelor's in Engineering, 4–10 years in quality engineering within medical devices, and strong experience with NCR, CAPA, risk management, and FDA/ISO 13485 practices.

Qualifications

• Bachelor's degree in Engineering or closely related field.
• Experience in a regulated industry, preferably medical devices.
• Strong analytical and problem-solving skills.

Responsibilities

• Provide Quality Engineering support in post-market and sustaining environments.
• Lead non-conformance investigations and disposition activities.
• Support CAPA investigations and timely resolution.

Skills

Quality Eng

NCR investigations

CAPA

Regulatory knowledge

FDA regulations

ISO 13485

Risk management

Data analysis

Cross-functional

Education

Bachelor's degree in Engineering

Tools

Quality Systems

Job description

Immediate need for a talented Senior Quality Engineer – Medical Devices. This is a 06+months contract opportunity with long-term potential and is located in Los Angeles, CA (Hybrid).

Job ID:26-27198

Pay Range: $60 - $63/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)

Key Responsibilities

• Provide Quality Engineering support for medical device products within a post-market and sustaining engineering environment.
• Lead and support non-conformance investigations, including technical assessment, root cause analysis, and disposition activities.
• Support CAPA investigations and corrective/preventive actions, ensuring appropriate documentation and timely resolution.
• Perform and support risk management activities, including evaluation and maintenance of product and process risk documentation.
• Analyze product and process quality data to identify trends, risks, and opportunities for improvement.
• Partner with Manufacturing and Operations Quality teams to investigate and resolve product and process quality issues.
• Collaborate with R&D, Engineering, Regulatory, Manufacturing, and other cross-functional teams to develop effective and compliant solutions.
• Provide quality engineering guidance to engineering and project teams throughout product lifecycle and post-market activities.
• Support quality activities associated with product launches, sustaining engineering, and ongoing product improvements.
• Prepare, review, and maintain accurate quality system documentation and technical records.
• Apply engineering judgment and structured problem-solving techniques to address complex quality issues.
• Ensure investigations and quality activities are completed in accordance with applicable quality systems, procedures, and regulatory requirements.
• Manage multiple investigations, projects, and competing priorities while maintaining a high level of quality and attention to detail.
• Support the quality organization in maintaining patient safety, product compliance, product performance, and continuity of therapy.

Key Requirements and Technology Experience

• Bachelor's degree in Engineering or a closely related technical discipline.
• 4–10 years of experience in Quality Engineering or a closely related quality function.
• Experience working in a regulated industry, preferably medical devices.
• Strong experience with one or more of the following:
• Non-conformance / NCR investigations
• CAPA
• Corrective and Preventive Actions
• Quality Systems
• Product and Process Quality
• Strong analytical and problem-solving capabilities.
• Excellent written and verbal communication skills.
• Demonstrated ability to work effectively with cross-functional engineering and business teams.
• Ability to independently manage multiple priorities and deliver high-quality work in a fast-paced environment.
• Experience in the medical device industry.
• Experience with post-market quality engineering or sustaining quality.
• Experience supporting diabetes, wearable, infusion, pump, monitoring, or connected medical devices.
• Knowledge of FDA regulations and medical device quality systems.
• Familiarity with ISO 13485 and risk management principles.
• Experience with structured root-cause methodologies and problem-solving tools.
• Experience working with Manufacturing, R&D, Regulatory, and Operations Quality organizations.
• Experience supporting product launches or sustaining engineering programs.

Our client is a leading Medical Equipment Manufacturing Industry, and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.