Quality EngineerSurf Search Inc • Carlsbad, CA
Quality Engineer
Surf Search Inc • Carlsbad, CA
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Responsible for Design Quality Assurance for Catheters and Devices containing software. Manage QMS functions related to management review, design control, risk management, CAPA, complaint handling, non-conformance, quality planning, document management, and change control. Lead post-market quality activities, including vigilance reporting / MDRs. Oversee complaint and CAPA systems, ensuring timely, accurate, and compliant documentation and reporting of MDRs or other actions. Review and approve master batch records and resolve quality issues. Maintain verification and monitoring programs to ensure QMS compliance with regulations and standards. Act as the Management Representative, ensuring compliance with regulatory requirements, international standards, and company policies. Direct Quality Assurance functions and lead inspections, audits, and compliance activities, maintaining relationships with regulatory bodies. Lead Supplier Quality initiatives and manage internal and external audit resolutions. Provide training on regulatory compliance, QMS, and related subjects. Support quality initiatives to improve the overall quality of released products. Perform and delegate responsibilities within QA to ensure timely achievement of company objectives. Adhere to all policies, procedures, and business ethics codes.
Join our cardiovascular EP client’s rapidly growing team and help as they embark on an exciting phase of their development! The company is eager to find a talented Quality Engineer to facilitate quality activities. This person will provide engineering support to new product development teams and / or sustaining manufacturing / operation teams. This role ensures products are developed per regulatory requirements, customer expectations, and industry standards. Additionally, the role will maintain the Quality Management System (QMS) infrastructure, ensuring it is compliant, making changes to the system as needed to maintain ease of use.
Qualifications of the Quality Engineer :
- A Bachelor’s degree in engineering or a related technical discipline, with a preference for mechanical, electrical, or chemical engineering.
- 4+ years of experience in quality engineering, especially in new product development.
- Quality experience with cardiovascular products and devices containing software – experience working with catheter devices is required.
- Experience with electromechanical devices, including 60601 testing requirements.
- Experience in validations (IQ, OQ, and PQ).
- Strong knowledge of Design Controls, Risk Management, and manufacturing process controls.
- Experience with FDA 21 CFR 820 and ISO Standards (ISO 13485 and ISO 14971).
- Proficiency in statistical methods, process design tools, and reading engineering blueprints (CMM, GD&T).
- Experience conducting risk analysis activities such as dFMEA, uFMEA, pFMEA, and hazard analysis.
- Strong technical writing skills for protocols, reports, and manufacturing procedures.
- ASQ Certified Quality Engineer (CQE) is preferred.
- Experience with FDA 21 CFR 210 & 211 is a plus.
Responsibilities of the Quality Engineer :
Occupational Category : 17-2199.02 Validation Engineers Application Instructions : Please apply using the form or send your resume to Surf Search.
[job_alerts.create_a_job]
Quality Engineer • Carlsbad, CA
[internal_linking.related_jobs]
Staffmark is partnering with a premier manufacturer in Vista, CA, to find a skilled Lamination lead.If you have a background in production, hand assembly, and composite materials, this could be the...[show_more]
We are a mission-driven company with the purpose to enable a safer, more sustainable world!.E provides a comprehensive suite of data, analytics, and software solutions for enabling and improving wo...[show_more]
Here at Hologic it is our purpose to enable healthier lives everywhere, every day.We are driven by our passion to become the global champion for women’s health.
We achieve this by fulfilling our pro...[show_more]
The application window is expected to close on 1 / 30 / 2026.This is an onsite role and will require working out of our Carlsbad, CA office location.
Work as part of a world class photonics team on the ...[show_more]
Flexible schedule • • • We will work with your schedule.Combine two of the fastest-growing fields on the planet with a culture of performance, collaboration and opportunity and this is what you get.Le...[show_more]
Are you interested in working for a company that fosters growth opportunities, community involvement and a team oriented atmosphere? ClarkDietrich, a leading manufacturer of cold-formed steel frami...[show_more]
Enovis Corporation (NYSE : ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcome...[show_more]
As a leading provider of aerospace and defense solutions we are dedicated to making air and space travel safe and sustainable.
We have 13 locations across North America and our engineering expertise...[show_more]
Estimated Starting Salary Range : USD $96,600.Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data...[show_more]
Registered Nurse (RN) - Correctional Quality Assurance - $53-66 per hour at CoreCivic summary : .The Registered Nurse (RN) Correctional Quality Assurance role at CoreCivic involves applying nursing s...[show_more]
Looking for an opportunity to make an impact? .Unleash your potential at Leidos, where we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated ...[show_more]
Ensures that products and services meet company standards and end-user requirements by analyzing and solving product conformance problems.
Performs quality planning tasks to ensure product conforman...[show_more]
FutureStitch is a fully-vertical circular manufacturer that believes business should be a force for good.We are the creators behind some of the world’s most beloved sock and ci...[show_more]
Cannon Building is a leading provider of high-efficiency, cost-effective construction solutions for Life Science, Healthcare, Commercial, and Industrial markets.
Our expertise includes critical envi...[show_more]
Mercor is hiring experienced Go Engineers • • to support a variety of high-impact research collaborations with leading AI labs.
Freelancers will help improve AI systems through work extending coding b...[show_more]
Quality Inspector Job Duties : Inspects and approves incoming materials by confirming specificati...[show_more]
There's a Place for You at OneSource Distributors.A career at OneSource is more than a job.You're investing in a brighter, more sustainable future together and joining a team that makes a real diff...[show_more]
Looking for an opportunity to make an impact?.Unleash your potential at Leidos, where we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our...[show_more]
Lamination Lead
Staffmark Group • Vista, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Staff AI Engineer
3e • Carlsbad, California, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Engineer, Design Control
Hologic • La Jolla, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Photonic Integration Engineer, Technical Leader
Cisco Systems, Inc. • Carlsbad, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Mammography Tech Per Diem, PRN
UnitedHealth Group • Vista, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Structural Project Engineer
ClarkDietrich • Carlsbad, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Supplier Quality Assurance Engineer
Enovis • Vista, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Engineer
Sonaca • Vista, California, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Sr Field Service Engineer
Scientific Research Corporation • Camp Pendleton, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
staff - Registered Nurse (RN) - Correctional Quality Assurance - $53-66 per hour
CoreCivic • Coronado, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Management Systems (QMS) Engineer
Leidos • Vista, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
MRO Quality Engineer Technician E
L3Harris • Carlsbad, California, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
VP of Merchandising & Design
FutureStitch • Oceanside, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Project Engineer- Healthcare
Cannon Building • Carlsbad, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Remote Backend Software Engineer : Go - AI Trainer ($80-$100 per hour)
Mercor • Vista, California, US
[filters.remote]
[job_card.part_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Inspector
TradeJobsWorkForce • 92138 San Diego, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Sr Project Manager - Sales
Sonepar USA • Oceanside, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Management Systems (QMS) Engineer
Leidos Inc • Vista, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]