Quality Systems Manager
Full Job Posting
Required Qualifications
- Bachelor’s degree and 8+ years of experience in Quality Assurance, Quality Systems, or related medical device quality functions.
- Minimum 1 year of people leadership, supervisory, or management experience.
- Strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and applicable medical device quality requirements.
- Experience managing audits, CAPA programs, document control, and Quality Management System activities in a regulated environment.
- Experience leading cross-functional projects and driving quality system improvements.
- Ability to analyze quality metrics and translate findings into actionable improvements.
- Strong written, verbal, organizational, and leadership skills.
- Quality certifications (ASQ CQE, CQA, or equivalent) preferred.
- This role is based onsite in Aliso Viejo, CA or Burlington, MA.
Preferred Qualifications
- Quality certifications (ASQ CQE, CQA, or equivalent) preferred.
Responsibilities
- Lead the implementation, maintenance, and continuous improvement of the QMS across the organization.
- Oversee key quality system functions, including document control, CAPA, internal audits, training, and management reviews.
- Drive quality and compliance initiatives by partnering with cross-functional teams to improve processes and regulatory readiness.
- Manage external audits and inspections, including preparation, execution, responses, and follow-up activities.
- Partner with cross-functional departments to drive quality system effectiveness and ensure consistent execution of quality processes and procedures.
- Develop, coach, and support quality team members while monitoring quality system performance metrics and continuous improvement efforts.
- How You’ll Get There
About Glaukos Corporation
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Glaukos Corporation
Interventional Glaucoma Business Manager
, USA
The Interventional Glaucoma Business Manager (iGBM) plays a critical role in driving the adoption and integration of Glaukos technologies within ophthalmic surgical practices. This individual will achieve quarterly sales
Area Director, Interventional Glaucoma
, USA
The ideal candidate will live in Los Angeles, San Diego or Orange County. Job Summary The Area Director will be responsible for leading a Sales Manager team to achieve top line revenue and sales targets, execute strategi
Interventional Glaucoma Business Manager
, USA
The Interventional Glaucoma Business Manager (iGBM) plays a critical role in driving the adoption and integration of Glaukos technologies within ophthalmic surgical practices. This individual will achieve quarterly sales
Interventional Glaucoma Business Manager
, USA
Interventional Glaucoma Business Manager
, USA
Area Director, Interventional Glaucoma
, USA
Interventional Glaucoma Business Manager
, USA
Area Director, Interventional Glaucoma
, USA
Glaucoma Reimbursement Liaison
, USA
Area Director, Interventional Glaucoma
, USA
Sr. Applied Research Engineer
Burlington, USA