Quality Engineer

Real; Santa Clara (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Real is seeking a proactive and technically strong Quality Engineer to support a fast-paced, highly collaborative product development environment. This role spans quality and manufacturing activities, contributing to development, process optimization, and commercialization efforts.

The ideal candidate will work independently with cross-functional teams, own design transfer and process qualification, drive improvements, and help resolve nonconformances throughout the lifecycle.

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.

Responsibilities

• Support integrated development and engineering (IDE) builds, repair activities, and clinical build initiatives.
• Contribute to De Novo program support and regulatory-related quality efforts.
• 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.

Skills

Quality Eng

QMS

Regulatory

FMEA

Nonconformance

Process Improvement

Documentation

Cross-functional

Job description

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

• Support integrated development and engineering (IDE) builds, repair activities, and clinical build initiatives
• Contribute to De Novo program support and regulatory-related quality efforts
• 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

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.