- Serve as the Management Representative, ensuring the adequacy and compliance of the QMS with all relevant regulatory standards.
- Mentor and develop the Quality Staff, fostering a culture aligned with the company's core values.
- Oversee all QMS activities, including but not limited to training, customer feedback management, deviations, corrective actions, supplier quality, and change control.
- Exercise judicious budget management in Quality operations.
- Provide expertise in quality assurance judgment and assessments.
- Continuously enhance the QMS to adapt to evolving business needs.
- Lead the Company Quality Objectives and facilitate their achievement.
- Conduct audits from regulatory agencies and ensure compliance with ISO 14971 for risk management.
- Drive quality actions based on data analysis from internal manufacturing, customer feedback, and device performance.
- Lead internal, external, and supplier audit activities.
- Manage quality plans and oversee the review and approval of components and finished products.
- Bachelor's degree in life science or related field, engineering, or scientific discipline preferred.
- Minimum of 7 years of quality experience in medical device, IVD, or biotech industries.
- At least 3 years in a leadership and direct line management role.
- Demonstrated competency in QMS governance and standards.
- Ability to thrive in a small to medium-sized early-stage commercial business environment.
- Expertise in relevant regulations including 21 CFR Part 820, ISO 13485, MDD, MDR, MDSAP, ISO 14971, cGDP, GMP, and 5S principles.
- Regular communication and occasional lifting of up to 25 pounds may be required.
- Work primarily in a general office environment with exposure to PCs and networks.
- Moderate noise level in the work environment.
- Travel may be necessary.
-
Quality Manager, Medical Device Company
1 week ago
Ignite Human Capital San Diego, United StatesWe are excited to share a new Quality Manager position with one of San Diego's best small medical device firms. They are on the move and ready for the next phase of growth, and this position is vital to the company. The perfect candidate would be able to lead a team of 2-3 people ...
-
Chief Finance Officer
3 days ago
Vaco San Diego, United StatesVaco Overview: Vaco provides expert consulting, permanent placement, executive search, and strategic staffing for companies around the world, in the areas of accounting, finance, operations, administration and more. As a premier talent solutions firm, Vaco connects people to thei ...
-
Sr. Manager, Process Development
4 weeks ago
Meet San Diego, United StatesWe are actively seeking a Manager OR Senior Manager of Process Development & Manufacturing for a growing medical device company in North County San Diego. The team is passionate about innovation and collaboration, with a focus on developing breakthrough class II/III cardiovascula ...
-
Wheelchair Service Technician
1 week ago
Ultimate Staffing San Diego, United StatesWheelchair Service Technician · Location: San Diego, CA 92131 · Hours: Monday - Friday 8:00 AM - 5:00 PM · Pay: $27 - $30/hr DOE · Must be able to pass a background check and have a clean motor vehicle record · Direct Hire · A medical supply company is seeking a Wheelchair ...
-
Regulatory Affairs Specialist
2 weeks ago
Cypress HCM San Diego, United StatesRegulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clini ...
-
Network Consultant
3 days ago
Domo Modular San Diego, United StatesCompany Description · DOMO Modular is a San Diego based Modular manufacturing and real estate development company looking for a network engineer to assist setting up an office network in its innovation lab, along with trouble-shooting smart home devices, range extenders, printers ...
-
MediaTek San Diego, United StatesMediaTek's Power Management team design power management integrated circuits (PMICs) and power management units (PMUs) for a variety of smart phones, IOT, automotive, and ASIC products. Our designs and products are widely used in hundreds of millions of devices each year. · We ar ...
-
Senior Staff
1 week ago
MediaTek San Diego, United StatesMediaTek Incorporated is a global fabless semiconductor company that enables nearly 2 billion connected devices a year. We are a market leader in developing innovative systems-on-chip (SoC) for mobile device, home entertainment, connectivity and IoT products. MediaTek is the numb ...
-
GPU Compiler Developer
1 day ago
MediaTek San Diego, United States*Location can be flexible - Open to San Jose, CA or San Diego, CA · MediaTek Incorporated is a global fabless semiconductor company that enables nearly 2 billion connected devices a year. We are a market leader in developing innovative systems-on-chip (SoC) for mobile device, hom ...
-
Senior Staff/Principal GPU Driver Engineer
1 week ago
MediaTek San Diego, United StatesMediaTek Incorporated is a global fabless semiconductor company that enables nearly 2 billion connected devices a year. We are a market leader in developing innovative systems-on-chip (SoC) for mobile device, home entertainment, connectivity and IoT products. MediaTek is the numb ...
-
Hardware Engineer
3 weeks ago
Devonics Automation San Diego, United StatesJob Description: · Devonics has an exciting opportunity for an eager IoT Hardware Engineer to contribute to a revolutionary new product and value proposition for B2B business. This individual is responsible for the development of Hardware and support Firmware IoT solutions to dem ...
-
FPGA Design Engineer
1 week ago
EVONA San Diego, United StatesFPGA Design Engineer · San Diego, California · Our client is a well-established and exciting Space company based in San Diego and they are looking for an FPGA Engineer to join an experienced team to help Design across their Systems. · JOB DESCRIPTION: · Responsible for the de ...
-
Embedded Software Engineer
2 days ago
Optizm Global San Diego, United StatesPosition: Embedded SW Developer · Location: San Diego, CA · Position Type: We are open to both full-time and part-time candidates (a contract or w-2 based on fit) · We are looking for an Embedded SW Developer preferably with a Zephyr and/or Nordic chipset background for an exciti ...
-
Staff Labeling Specialist
1 week ago
Stryker San Diego, United States Full timeWhy engineering at Stryker? · At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make health ...
-
General Services Technician
3 weeks ago
SeaWorld Parks & Entertainment San Diego, United States Part timeJoin us at Sesame Place and help bring joy, excitement, and lasting memories to people from around the world. We're seeking enthusiastic, dedicated, and hard-working individuals to become our Ambassadors. Come and play an important part on our incredible team today · What you get ...
-
Principal Design Assurance Electrical Engineer
3 weeks ago
Philips San Diego, United States Full timeJOB DESCRIPTION Job Title · Principal Design Assurance Electrical Engineer (Hybrid) Job Description · Principal Design Assurance Engineer (San Diego-Hybrid, 3 days onsite weekly) · The Principal Design Assurance Engineer will be responsible for providing quality engineeri ...
-
Staff Process Development Engineer
1 week ago
Dexcom San Diego, United StatesAbout Dexcom · Founded in , Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming di ...
-
Soliant San Diego, United StatesMinimum 1+ years speech therapy experience required. · Soliant · Position Title: Speech Language Pathologist · Location: San Ysidro, California · Term: One full school year (8 months) Opportunity to renew contract annually · Type: Full-Time (40 hours per week) · **U.S. Work Auth ...
-
MediaTek San Diego, United StatesWe welcome all curious engineers, solution-oriented thinkers, innovative persons who are looking for a place to do their best work on automotive projects · What You Will Do · Early-stage analysis and evaluations of functional safety architectures used in both, conventional emerge ...
-
Building Engineer
1 week ago
ABM San Diego, United States Full timeABM, a leading provider of integrated facility solutions, is looking for a Building Engineer.The Building Engineer supports the designated leadership with the daily operations of all building systems. This includes hard surface maintenance and repair, basic carpentry and metal wo ...
Quality Manager, Medical Device Company - San Diego, United States - Ignite Human Capital
Description
Job Description
Job DescriptionWe are excited to share a new Quality Manager position with one of San Diego's best small medical device firms. They are on the move and ready for the next phase of growth, and this position is vital to the company. The perfect candidate would be able to lead a team of 2-3 people while remaining hands-on. The company has a very close culture and the people are kind, easy to work with and dynamic in their respected fields. Here is more about the role;
POSITION SUMMARY:
As an integral member of the Leadership Team, the Quality Manager assumes the role of Management Representative according to ISO 13485 standards. This position requires a dynamic individual who will serve as the Subject Matter Expert in Quality, providing regular updates to Executive Management on the status of the Quality Management System (QMS). The ideal candidate will be hands-on, proactive, and collaborative, dedicated to ensuring compliance with regulatory standards and fostering a culture of quality excellence within the organization.
ESSENTIAL RESPONSIBILITIES:
EDUCATION/EXPERIENCE REQUIREMENTS:
KEY QMS GOVERNANCE and STANDARDS:
PHYSICAL DEMANDS & WORK ENVIRONMENT:
COMPENSATION:
Between $115-140K base, plus bonus - with title and compensation level depending on experience.
Powered by JazzHR
8nb2Hu9Sfx
Quality Manager, Medical Device Company professionals in San Diego
-
David Mercadel
3D Asset Artist
-
Kristine Afanse
Business Development
-
Eleanna Sakoulas
Clinical Research Assistant
-
yvette villanueva
Quality Engineer
-
Joey Baxter
Teaching chemistry to high school and college students is my passion.
-
Mark Vaughn
Engineering Manager