Sr. Engineer, Quality

Job Description

Job Title:

Sr. Quality Engineer

Reporting to:

Vice President, Quality and Regulatory

Location:

San Jose, California

Job Site:

On-Site

Job Description Revision Date:

December, 2025

About us:

We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 has offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.

PURPOSE

Provides senior-level Quality Engineering leadership supporting design, development, transfer, and manufacture of medical devices and specialized instrumentation. Establishes, maintains, and improves Quality System processes ensuring compliance with FDA QSR, ISO 13485, ISO 14971, and customer requirements.

SPECIFIC DUTIES AND RESPONSIBILITIES

Quality System Ownership & Leadership:

- 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.

Design & Development / Design Transfer:

- 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.

Supplier Quality & Manufacturing Support:

- 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.

CAPA / Nonconformance / Post-Market Quality:

- 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.

Audit & Regulatory Support:

- 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.

Customer & Cross-Functional Interface:

- 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.

SUPERVISORY RESPONSIBILITIES

May provide technical mentorship to Quality Engineers, Document Control partners, and Quality Specialists.

No direct managerial responsibilities unless assigned.

EDUCATION

Bachelor’s degree in Engineering, Life Science, or related technical field required.

Professional certifications (e.g., ASQ CQE, CQA, CMQ/OE) are preferred but not required.

EXPERIENCE

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.

KNOWLEDGE, SKILLS AND TRAINING

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.

Full-time