Sr. Quality Manager

Help grow a safer, cleaner, healthier future for everyone, every day.

Sr. Quality Manager
Company: Surgistar
Location: Vista, CA

Department: Quality

Reports To: Sr. Director, Plant Operations/GM

About Us

We are a division of MicroSurgical Technology (MST), that develops, manufactures, and markets medical devices for the ophthalmology market. Our products are manufactured using the highest levels of care and precision at our manufacturing facility in Vista, California. We constantly evolve to meet the distinct clinical needs of ophthalmic surgeons through our dedicated partnership with surgeon-designers, bringing innovation to ophthalmology.

Key Responsibilities

Quality Management System (QMS)

• Implement, maintain, and improve the QMS to align with standard ISO 13485

• Oversee day-to-day quality control processes, batch record reviews, and final product release.

• Manage Corrective and Preventive Actions (CAPA), nonconformances, and customer/internal complaints.

Regulatory Affairs (RA) & Compliance

• Supporting Corporate RA group for regulatory filings, registrations, and product submissions (such as 510(k) clearances for medical devices).

• Act as the primary liaison for external regulatory bodies, auditors, and client inspections (e.g., FDA, ISO registrars).

• Evaluate proposed product or process changes for regulatory impact and compliance.

Leadership & Cross-Functional Collaboration

• Lead, mentor, and develop the quality team.

• Partner with Manufacturing, R&D, Engineering, and Supply Chain to resolve quality deviations and reduce waste.

• Track and present quality metrics/KPI’s (defect rates, scrap rates, audit findings) to executive leadership.

Qualifications & Requirements

• Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

• Experience: 6 to 10 years of progressive experience in QA/RA within a regulated manufacturing environment (e.g., medical device, pharma, biotech)

• Leadership: 2+ years of supervisory or team management experience.

• Technical Skills: Deep knowledge of cGMP, FDA regulations, ISO standards, and risk management tools (FMEA, root-cause analysis).

Compensation (California Pay Transparency):

The good‑faith annual base salary range for this non-exempt position is $130K-$160K at the time of posting. Actual compensation will be determined based on job‑related factors permitted by law, such as relevant experience, education, knowledge, skills, abilities, and internal equity.

Benefits:

This position is eligible for a comprehensive benefits package, subject to plan terms and eligibility requirements.

EEO/AA: Surgistar is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin (including ancestry), sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), sexual orientation, gender identity or expression, age, marital status, medical condition, genetic information, disability, protected veteran status, or any other characteristic protected by applicable law. Surgistar will not retaliate against applicants or employees for exercising rights protected by law, including requesting pay scale information.

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