Position Title: Quality Assurance Manager

Location: Hybrid or Remote (reports into Zyris headquarters based in Goleta, CA)

Our purpose

At Zyris, we are radically improving the experience of dentistry for patients and clinicians. We believe positive dental experiences are completely achievable, but too many people have a history of the opposite. We actively collaborate with the dental community to design tools that make dentistry safer, more effective, and comfortable—helping dental practices thrive. Join us in creating a world with better oral health for everyone.

Position Summary / How You Will Contribute:

The Quality Assurance Manager at Zyris plays a pivotal role in upholding regulatory compliance and fostering a culture of quality throughout the organization. Responsible for managing the Quality System in alignment with global medical device requirements, the QA Manager oversees QA staff, serves as the Management Representative, and ensures the effectiveness of the quality system. The role reports to the VP of Operations and involves collaborative tasks as assigned.

Key Performance Areas & Expectations:

1. Establishing and Maintaining Quality System:

- Develop, optimize, and execute controls for a comprehensive Quality System in compliance with QSR-21 CFR Part 820-GMP, ISO13485-2016, and EU Medical Device Regulations.

- Lead documentation control, change management, design control, validation, verification, and other quality-related processes.

1. Collaboration and Process Integration:

- Work collaboratively with internal customers, ensuring Quality processes are integrated during product design.

- Collaborate with Product Development, Marketing, and Customer Success teams on labeling, packaging, and complaint investigations.

1. Executive Reporting:

- Provide biannual quality system data to the Executive Team through Management Reviews.

1. Leadership and Employee Development:

 - Manage and supervise the Quality Assurance staff.

- Provide ongoing feedback, mentorship, and support for employee career development.

- Assist employees in overcoming obstacles to achieving their goals in a timely manner.

1. Quality Improvement and Audits:

- Develop the cross-functional Quality Improvement Team (QIT) and conduct regular reviews of quality inputs and outputs.

- Direct, perform, and participate in internal audits of the company’s quality management system.

- Assist in Root Cause Investigations using tools like 5-Why Analysis.

Company Values and Traits:

- Learn, embody, and promote company values and traits.

- Continuously enhance competency and contribute to the world-class example in areas of responsibility.

- Demonstrate a commitment to excellence and quality in work.

- Contribute enthusiastically, even beyond normal duties.

- Provide clear, honest, and direct communication to team members at all levels.

Preferred Traits and Abilities for a Quality Assurance Manager:

- Results orientation with strong time management skills.

- Excellent verbal and written communication skills.

- Ability to work independently and collaboratively within cross-functional teams.

- Strong judgment and decision-making capability in technical and quality domains.

- Exceptional attention to detail, organizational skills, and consistent record-keeping diligence.

- Solid work ethic and high self-motivation.

Qualifications (Knowledge and Experience Required):

- In-depth knowledge of QA techniques, systems, practices, ISO, and FDA compliance.

- Three to five years of experience in Quality Assurance, with a minimum of three years in the medical device industry.

- Two to five years of experience working with notified bodies (CE mark) and other regulatory agencies.

- Undergraduate degree (Bachelor) in a Science or Engineering discipline, or a minimum of five years' experience in Quality Assurance.

- Previous experience with SAP Business One/Microsoft Dynamics 365 or comparable ERP system is a plus.

- Previous experience with an eQMS system is a plus.

-Ability to effectively work hybrid or remote; and ability to travel as required by business needs.

Additional Information

Even if you don’t meet each requirement, we encourage you to apply. Your skills and experience may be relevant beyond this list of qualifications. The pay range for this position is $95,000 - $135,000. Zyris is committed to offering competitive, fair, and commensurate compensation, and the pay range provided is the range that we reasonably expect to pay for this role. Actual compensation offered will be determined based on criteria permitted under applicable law including but not limited to a candidate’s job-related skills, experience, education or training, and location.

Benefits: Zyris offers a comprehensive package of benefits including time off, medical/dental/vision insurance, 401(k), and other benefits subject to eligibility requirements.

Wellness of body, mind, and wallet!

• Medical, dental and vision insurance: 100% coverage for you, 75% coverage for your dependents
• 401(k) plan (dollar for dollar match, up to 4% of your salary)
• Life Insurance, short-term and long-term disability benefits
• EAP and other wellness benefits to support your physical and mental well-being

Time Off!

• Take the time you need to rest and recharge, there are no preset limits
• Take time off to care for yourself or family member. Up to 10 days per year.
• Time off to volunteer and contribute to the community

Investing in your growth!

• Professional development tailored to your needs
• The time and space to learn, prioritized at all levels of the company

There’s more!

• Remote & Hybrid work
• Fun company events
• Access to lots of joy and laughter

About Zyris

We’re a family business that was envisioned during a holiday dinner by a dentist, an industrial designer, and an accountant. The dentist complained of physical strain and visibility challenges. After much brainstorming and experimenting, a new way of practicing dentistry was born in 2001 with the launch of our Zyris Isolite dental isolation system. As a result, over 100 million dental procedures at over 15,000 locations have had better clinical outcomes with ease and efficiency.

Our company culture embodies an entrepreneurial spirit by encouraging employees to speak up and pursue new ideas, with an eye on long-term customer success. We live our core values, while supporting each other and the greater dental community.

Equal Opportunity Employer

We are an equal opportunity employer and believe that diverse perspectives enrich and strengthen our company culture. We encourage and invite all qualified applicants of every background, ability, race, religious creed, color, national origin, ancestry, medical condition, marital status, gender identity or expression (including pregnancy, childbirth, or related medical condition), age, sexual orientation, military or veteran status, political affiliation, and any other protected classification.

Zyris is committed to diversity, equity, and inclusion, both in our hiring practices and in our employee experience. We celebrate differences, and together we have cultivated a respectful environment where everyone can show up authentically. Harassment, racism, and discrimination are never tolerated.