gener8 · 15 hours ago
Sr. Engineer, Quality
San Jose, CA
Full-time
Onsite
Senior Level, Lead/Staff
$104K/yr - $174K/yr
10+ years expGener8 is a company that specializes in providing engineering design services and manufacturing for the life sciences and medical industries. They are seeking a Senior Quality Engineer to lead quality engineering efforts, ensuring compliance with regulatory standards and improving quality systems for medical devices and instrumentation.
ManufacturingSoftware
No H1B
U.S. Citizen Only
Responsibilities
Provide leadership in the development and maintenance of Quality System procedures, work instructions, and forms
Lead Quality document creation, review, and approval; oversee ECO/ECN processes and ensure compliant implementation
Provide oversight and subject matter expertise for document control workflows, including ECO routing, controlled document lifecycle management, and template maintenance, as part of the shared Quality System model. Gener8 does not maintain a dedicated Document Control department; these responsibilities are distributed across senior Quality personnel
Act as an internal SME for ECO workflow design, template governance, and controlled document structure to ensure consistent implementation across Engineering and Operations
Drive continuous improvement to ensure compliance with evolving regulatory and customer requirements
Support design controls, verification/validation, risk management (ISO 14971), and traceability
Partner with Engineering to define product and process quality requirements
Ensure DHF and DMR documentation is compliant, complete, and audit-ready
Support supplier qualification, monitoring, and re-evaluation processes
Assist manufacturing engineering with process validation, nonconformance analysis, and quality record creation
Support controlled builds, process changes, and documentation updates
Lead or mentor high-risk CAPA investigations ensuring robust root cause and corrective actions
Support post-market quality activities including complaint investigations and RMA assessments
Perform trend analysis and drive actions to prevent recurrence
Support internal audits, FDA inspections, notified body audits, and customer audits
Prepare QMS documentation and provide SME support during auditor interviews
Maintain inspection readiness across assigned quality processes
Interface with customers to clarify quality expectations and documentation requirements
Collaborate with Engineering, Operations, and Supplier Quality to resolve quality activities
Communicate quality risks, system gaps, and improvement opportunities to leadership
May provide technical mentorship to Quality Engineers, Document Control partners, and Quality Specialists
Qualification
Required
Bachelor's degree in Engineering, Life Science, or related technical field required
10+ years Quality Engineering experience in medical device, biotech, or regulated manufacturing environments
Demonstrated experience with design controls, risk management, QMS ownership, and supplier quality
Experience supporting audits and interacting with regulatory bodies and customers
Expert knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, and applicable IEC standards
Strong technical writing, procedure development, and documentation skills
Proficiency in eQMS workflows, document control systems, and ECO routing logic
Ability to analyze data, perform root cause investigation, and drive corrective actions
Strong interpersonal and communication skills with ability to influence cross-functional teams
Ability to manage complex projects, prioritize effectively, and make risk-based decisions
Preferred
Professional certifications (e.g., ASQ CQE, CQA, CMQ/OE) are preferred but not required
Benefits
Health, Dental and Vision insurance
401(k)
Life insurance
STD
LTD
Flexible spending account
Health savings account
Paid time off
Employee discounts
Referral program
Company
gener8
Gener8 is an electronic manufacturing company providing electronic, mechanical, optical, firmware, and software design services.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2018-08-21Acquired
Leadership Team
Mark Chatfield
Global Vice President of Operations
David Klein
Founder
Recent News
2025-05-28
2023-03-17
Startup Around
2023-03-16
Company data provided by crunchbase