Medical Device - Senior Quality Management Specialist

Job Description

Job Description

JOB OBJECTIVES:

The Senior Quality Management Specialist will be responsible for ensuring the quality and compliance of our medical devices by independently implementing, maintaining, and continuously improving quality management systems in accordance with ISO 13485, FDA 21 CFR Part 820, and MDSAP regulations. This role will work closely with the Director of Regulatory Affairs/Quality Assurance (RA/QA) and cross-functional teams, providing subject matter expertise and mentorship to junior quality staff, to ensure that all products meet the highest standards of quality and safety. This position is based in our headquarters in Walnut Creek, California.

JOB DUTIES:

• Lead cross-functional collaboration with Engineering and Product Management teams to process Change Orders and create Engineering documentation in Arena (item numbers, BOM development, artwork approvals, etc.), ensuring compliance with applicable design control requirements.
• Own and drive continuous improvement of Document Control processes and procedures in accordance with department and company goals.
• Independently lead root cause investigations and drive Corrective/Preventive Actions (CAPAs) and Supplier Corrective Actions (SCARs) through closure and effectiveness verification.
• Lead Supplier Controls activities, including planning and conducting supplier audits and qualifications.
• Own complaint handling metrics and trend analysis, escalating quality risk signals to the Director of RA/QA, and manage the closure of related repairs.
• Oversee the annual calibration calendar and training program, ensuring timely completion and audit readiness.
• Partner with Product Management to manage documentation for active Arena Project Plans and maintain associated templates.
• Perform other duties as requested to support company quality and product development initiatives.
• Support preparation of quality metrics, trend reports, and inputs for management review.

REQUIREMENTS:

• Minimum of 5–7 years of experience in a quality role in a medical device environment. Demonstrated experience leading internal/supplier audits and CAPA investigations is required.
• Bachelor’s degree in a relevant field such as Engineering, Quality or Biology.
• Strong knowledge of medical device regulations and standards, including ISO 13485 and FDA 21 CFR Part 820 required; working knowledge of MDSAP, ANVISA, and EU MDR strongly preferred.
• Strong working knowledge of Adobe Acrobat, and MS Office.
• Ability to work in a high volume fast paced environment with minimal oversight, exercising sound judgment on complex or ambiguous assignments.
• Represent Quality in cross-functional and management discussions.
• Ability to work in a team environment and manage multiple tasks simultaneously with a disciplined approach for completing tasks on schedule.
• Excellent written and verbal communication skills.
• Possess strong organizational skills and attention to detail.
• Proven ability to complete projects according to outlined scope, budget, timeline, and expectations.
• An ability to be flexible, adaptable, and work under pressure.

This job description is not exhaustive, and the role holder may be required to undertake additional duties or responsibilities as required.

\nCompany Description

Why We Exist

We believe good oral care is critical to everyone’s health and wellness. Dental professionals and consumers alike should have access to technologies that improve oral health. We are committed to the belief that these technologies should be proven effective through empirical evidence, have elegant & intuitive design, and be as minimally invasive as possible.

How We Work

At Azena, every insight is given a chance to develop, to be validated by science and clinical research, and to inspire the creative minds of our designers and engineers. We continually challenge ourselves to explore innovation for the betterment of oral healthcare. We base our innovation on the foundations of science and aesthetic design to create effectiveness, simplicity, ease-of-use, and overall appeal.

What We Do

With a focus on improving oral healthcare, we design, develop, validate, manufacture, and market world-class devices for both dental clinicians and consumers. We are continually searching for new solutions to enhance oral care. Our offerings are created at the intersection of where art, science, and technology meet.

Join Our Team

Azena's team of engineers and designers have experience developing, manufacturing, and marketing Class IV surgical laser systems for professional dental applications, as well as other dental and oral care products.

Our current suite of professional dental products is distributed in 50+ countries globally. More than a million procedures have been performed using our devices in dental offices all over the world. These products have won numerous design and clinical effectiveness awards, and are widely recognized as leaders within their segments.

We are based in Walnut Creek, California, we are an affiliate of an international organization, and our products are manufactured locally in the San Francisco Bay Area.

Company Description

Why We Exist\n\nWe believe good oral care is critical to everyone’s health and wellness. Dental professionals and consumers alike should have access to technologies that improve oral health. We are committed to the belief that these technologies should be proven effective through empirical evidence, have elegant & intuitive design, and be as minimally invasive as possible. \n\nHow We Work\n\nAt Azena, every insight is given a chance to develop, to be validated by science and clinical research, and to inspire the creative minds of our designers and engineers. We continually challenge ourselves to explore innovation for the betterment of oral healthcare. We base our innovation on the foundations of science and aesthetic design to create effectiveness, simplicity, ease-of-use, and overall appeal. \n\nWhat We Do\n\nWith a focus on improving oral healthcare, we design, develop, validate, manufacture, and market world-class devices for both dental clinicians and consumers. We are continually searching for new solutions to enhance oral care. Our offerings are created at the intersection of where art, science, and technology meet.\n\nJoin Our Team\n\nAzena's team of engineers and designers have experience developing, manufacturing, and marketing Class IV surgical laser systems for professional dental applications, as well as other dental and oral care products.\n\nOur current suite of professional dental products is distributed in 50+ countries globally. More than a million procedures have been performed using our devices in dental offices all over the world. These products have won numerous design and clinical effectiveness awards, and are widely recognized as leaders within their segments.\n\nWe are based in Walnut Creek, California, we are an affiliate of an international organization, and our products are manufactured locally in the San Francisco Bay Area.