Cirtec Medical · 8 hours ago
Quality Manager
Santa Clara, CA
Full-time
Onsite
Senior Level
$140K/yr - $165K/yr
7+ years expCirtec Medical is a leading outsourcing partner for complex medical devices, specializing in solutions for Class II and III devices. The Quality Manager will lead the Quality personnel and ensure compliance with the Quality Management System while overseeing Quality engineering activities to support manufacturing operations and product development programs.
Medical Device
Responsibilities
Responsible for oversight and compliance of the Quality Management System
Responsible for ensuring that the processes needed for the Quality System requirements are established and maintained in accordance with applicable regulations and standards
Responsible for ensuring the promotion and awareness of applicable regulatory requirements and Quality Management System requirements throughout the site’s organization
Responsible for leading Management Review meetings and reporting on the performance and effectiveness of the Quality System, as well as any improvements needed, for periodic review and analysis
Oversee Complaint Analysis and Corrective and Preventive Action Systems, and the tracking / reporting of metrics
Lead and manage the Quality Engineering staff responsible for Design & Development as well as Sustaining Manufacturing activities
Manage Quality Control staff to provide incoming (receiving & inspection), in-process inspection, final inspection, and product release activities for all manufacturing programs
Responsible for overseeing or delegating the creation of QMS related Quality Plans that are site-specific
Provide organizational leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams
Drive and support corporate Quality Management System initiatives
In partnership with other Cirtec Medical Quality Leaders, ensure establishment and maintenance of site registrations (e.g., ISO 13485 and FDA)
Act as site champion for Quality Best Practices and cGMP within Cirtec Medical
Ensure accountability for Design and Development management of internal and customer development programs and design transfers
Provide Quality Engineering support for internal and customer development programs and sustaining manufacturing process/continuous improvement efforts
Initiate and/or collaborate in the generation/update of process / product Risk Management documentation, e.g., FMEAs and Hazard Analysis, in collaboration with cross-functional engineering teams
Develop and perform qualifications and validations for manufacturing processes in collaboration with cross-functional engineering teams per project requirements
May author, review and/or approve documentation for process and design change activities as well as validation / verification oversight and/or test method execution in cooperation with cross-functional engineering teams per project requirements
Represent Quality Engineering in program / project phase reviews throughout the product development and transfer to manufacturing phases and process improvement initiatives
Support and oversee the Nonconformance Materials Review Board process
Manage metrology and calibration activities
Primary lead for external regulatory, certification, and customer audits
Manage support for local and corporate Documental Control (PLM) and Material Resource Planning (MRP) systems implementations, integrations, and improvements
Manage Quality Systems staff to provide Documentation Control and records retention functions, Incoming/Final Inspection, Complaint Analysis, Corrective Action System and Quality Control training to Customer Focused Business Units
Qualification
Required
Bachelor in STEM related field required
Minimum 7 years of experience in a regulated medical device environment, preferably as a Sr. or Principal Quality Engineer or Quality Manager, with supervisory and decision-making responsibilities
Quality and/or Regulatory certification(s) (ASQ, Lead Auditor, etc.)
Knowledge and experience with external standards and regulations: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints
Experience with Class II and Class III medical device development and manufacturing
Demonstrable knowledge and experience with Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation
Experience in effectively managing audits by customers and regulatory agencies
Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement
Strong verbal and written communication skills. Ability to present complex information to internal and external contacts
Experience being a 'Hands-on' self-starter with ability to work both independently and as part of a team
Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access
Experience in coaching and developing direct reports, utilizing performance management tools and disciplines, while increasing employee engagement and retention
Preferred
Advanced degree preferred
Benefits
Training and career development
Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid Time Off
401(k) retirement savings with a company match
Company
Cirtec Medical
Whether you’re a cutting-edge startup or a leading Class II or III medical device manufacturer, Cirtec is here to help bring life-enhancing therapies to market – quickly and cost-effectively.
1001-5000 employees
H1B Sponsorship
Cirtec Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (4)
2022 (2)
2021 (3)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Brian Highley
CEO
John Kraus
Chief Operations Officer
Recent News
2025-10-02
2025-09-17
2025-08-29
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