Akkodis is looking hands-on Design Assurance Engineer who can manage product quality across the full lifecycle (NPD to post-market) in a medical device environment.
Title: Quality Engineer
Location: Carlsbad CA
Contract: 12 months+ Extendable
Pay Rate: $50 hr. -$60/hr. (The rate may be negotiable based on experience, education, geographic location, and other factors)
Job Description:
As a Design Assurance Engineer, you will support new product development and commercialized products that improve the delivery of care for patients around the world.
In this highly visible role, you will influence design strategy, risk management, and lifecycle quality activities while partnering with cross-functional leaders in R&D, manufacturing, regulatory, and clinical. You will thrive in a high-performance culture that values diversity, innovation, global collaboration and a winning spirit where continuous learning and bos impact are part of every project.
Your responsibilities will include:
Apply advanced, systematic problem-solving methodologies to resolve complex product and process quality issues across the product lifecycle.
Provide quality engineering insights on cross-functional new product development teams, ensuring robust design inputs, verification and validation strategies and regulatory compliance.
Drive the implementation and continuous improvement of risk management activities, including hazard analysis, fault tree analysis and FMEAs, ensuring alignment with ISO 14971 and internal standards.
Develop and approve verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.
Execute design change control activities, assessing product and process impacts while ensuring compliance and patient safety.
Monitor field performance of new and established medical devices, analyze trends against risk assessments and drive corrective and preventive actions as needed.
Mentor junior engineers and contribute to the development of best practices that elevate team capability and performance.
Qualifications:
Required qualifications:
Bachelor of Science degree in Engineering or a related technical field.
Minimum of 3 years' experience in quality engineering or design assurance within the medical device industry.
Demonstrated expertise in risk management, design controls and product verification and validation.
Strong knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971.
Proven ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels.
Strong written and verbal communication skills.
Ability to manage multiple priorities and navigate ambiguity in a fast-paced environment.
Preferred qualifications:
Degree in biomedical or mechanical engineering.
Experience supporting structural heart, cardiovascular or implantable medical devices.
Certification in quality engineering (e.g., CQE) or related credential.
Demonstrated use of advanced quality tools and statistical methodologies.
Passion for continuous improvement, talent development and building high-performing teams.
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit
https://www.akkodis.com/en/privacy-policy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
· The California Fair Chance Act
· Los Angeles City Fair Chance Ordinance
· Los Angeles County Fair Chance Ordinance for Employers
· San Francisco Fair Chance Ordinance
