Quality Engineer

Real Staffing; San Jose (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Real Staffing in San Jose, CA seeks a proactive Quality Engineer to support product development, manufacturing, and commercialization. You will work across design transfer, qualification, and process improvement in a fast-paced, collaborative environment.

The role emphasizes independent work, cross-functional partnerships, and meticulous documentation. Candidates should have strong QMS knowledge, experience with FMEAs, and the ability to drive risk reduction and lifecycle documentation.

Qualifications

• Experience with Quality Management Systems in a regulated environment.
• Ability to learn complex products, subassemblies, and manufacturing processes quickly.
• Proven quality engineering background in manufacturing support or related field.
• Experience supporting process qualification, FMEAs, and nonconformance activities.
• Ability to work independently while managing multiple priorities.
• Strong collaboration and problem-solving skills across teams.

Responsibilities

• Participate in design transfer activities, including execution and documentation.
• Manage and support nonconformance investigations and resolution activities.
• Lead and contribute to Process FMEA development and updates.
• Develop, review, and maintain manufacturing and quality documentation.
• Drive process improvements and continuous improvement initiatives.
• Support process qualification activities, including protocol development and report generation.
• Participate in design reviews, residual risk assessments, and lifecycle documentation updates.
• Collaborate cross-functionally to identify issues and drive effective solutions.

Skills

QMS knowledge

FMEA experience

Design transfer

Cross-functional collaboration

Problem solving

Job description

Overview

We are seeking a proactive and technically strong Quality Engineer to support a fast-paced and highly collaborative product development environment. This role offers the opportunity to work across a wide range of quality and manufacturing activities, contributing directly to product development, process optimization, and commercialization efforts.

The ideal candidate is dependable, detail-oriented, and capable of operating independently while partnering effectively across cross-functional teams.

Key Responsibilities

• Participate in design transfer activities, including execution and documentation
• Manage and support nonconformance investigations and resolution activities
• Lead and contribute to Process FMEA development and updates
• Develop, review, and maintain manufacturing and quality documentation
• Drive process improvements and continuous improvement initiatives
• Support process qualification activities, including protocol development and report generation
• Participate in design reviews, residual risk assessments, and lifecycle documentation updates
• Collaborate cross-functionally to identify issues, bring together key stakeholders, and help drive effective solutions

Qualifications

• Strong understanding of Quality Management Systems (QMS) within a regulated environment
• Demonstrated ability to quickly learn complex products, subassemblies, and manufacturing processes
• Proven technical capability in quality engineering, manufacturing support, or a related field
• Experience supporting process qualification, FMEAs, and nonconformance activities
• Ability to work independently with minimal oversight while managing multiple priorities
• Strong collaboration and problem-solving skills, with the ability to engage cross-functional teams

Preferred Skills

• Experience in medical device or highly regulated industries
• Exposure to design transfer, clinical builds, or regulatory submission support
• Familiarity with risk management processes (e.g., FMEA, hazard analysis)
• Experience supporting products through development and commercialization phases

What Sets You Apart

• Proactive mindset with a willingness to step into unfamiliar areas and learn quickly
• Strong technical foundation paired with hands‑on execution
• Ability to contribute meaningfully across a broad range of quality initiatives
• Effective communicator who can present ideas clearly and grow influence with stakeholders at all levels

Growth Opportunity

This role provides significant exposure across nearly all aspects of quality engineering within a product lifecycle. You will have the opportunity to deepen your expertise in areas such as process qualification, risk management, and cross‑functional leadership, while expanding your visibility and impact within the organization.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.