Position Overview:

We are seeking a highly skilled and detail-oriented Senior Quality Engineer to join our Quality team. Reporting to the Quality Manager, this role is responsible for leading and supporting quality activities across product development, design and process changes, supplier quality, and field failure investigations. The Senior Quality Engineer serves as a key technical quality partner to Engineering, Manufacturing, and external customers, ensuring products meet internal quality standards, customer expectations, and applicable regulatory and compliance requirements.

In this role, you will guide cross-functional teams on product requirements, risk management, Design History File (DHF) completeness, failure analysis, and corrective actions, while supporting global product and materials compliance efforts. This position requires strong technical judgment, influence without authority, and the ability to translate quality data into actionable improvements.

Key Responsibilities:

Quality & Risk Management

• Facilitate and support the development of design requirements based on market and customer needs.
• Lead and maintain Design FMEA (dFMEA) and Process FMEA (pFMEA) activities.
• Ensure completeness, accuracy, and ongoing maintenance of Design History Files (DHF).
• Partner with Product Development and Manufacturing Engineering to ensure robust design controls and risk mitigation.

Failure Analysis & Corrective Actions

• Oversee structured failure analysis of returned or nonconforming units, including documentation and reporting.
• Lead root cause analysis using established problem-solving methodologies (e.g., 8D, Fishbone, 5 Whys).
• Drive effective Corrective and Preventive Actions (CAPA) and verify their effectiveness.

Customer-Facing Quality

• Act as the primary quality technical contact for customers regarding field failures and corrective actions.
• Communicate investigation results, root causes, and improvement plans clearly and professionally to internal and external stakeholders.
• Support customer audits, inquiries, and quality reviews as needed.

Compliance & Certification

• Support product, electrical, and materials compliance activities to meet domestic and international market requirements.
• Collaborate with cross-functional teams to ensure compliance considerations are integrated into product development and changes.

Quality Systems & Audits

• Support maintenance and continuous improvement of the ISO 9001 Quality Management System.
• Participate in internal, customer, and third-party audits; support audit preparation, responses, and corrective actions.

Supplier Quality & Improvement

• Evaluate new suppliers to ensure compliance with quality standards and long-term capability.
• Monitor supplier performance metrics and lead supplier corrective actions and improvement initiatives.
• Collaborate with Supply Chain and Engineering to resolve supplier-related quality issues.

Data-Driven Quality & Continuous Improvement

• Apply statistical and quality tools (SPC, DOE, MSA, capability analysis) to monitor and improve product and process performance.
• Analyze quality data to identify trends, risks, and opportunities for improvement

Coaching & Technical Leadership

• Mentor engineers and cross-functional partners on quality tools, risk analysis, design controls, and structured problem-solving.
• Provide technical leadership and guidance without direct supervisory responsibility.

Documentation & Reporting

• Maintain accurate, timely, and compliant quality records and documentation.

Qualifications:

Required

• Bachelor's degree or higher in Chemical Engineering, Mechanical Engineering, or a related technical field.
• Minimum of 4 years of progressive experience in quality engineering or a closely related role.
• Demonstrated expertise in risk management, including dFMEA, pFMEA, Design History Files (DHF), and design control processes.
• Proven experience conducting failure analysis, root cause investigations, and driving Corrective and Preventive Actions (CAPA), preferably using structured methodologies such as 8D.
• Strong written and verbal communication skills, with experience interfacing directly with customers and suppliers on quality matters.
• Proficiency in statistical analysis and quality tools, preferably using JMP or equivalent software.
• Working knowledge of ISO 9001 and/or other quality and risk standards (e.g., ISO 13485, ISO 14971).
• Experience using electronic Quality Management Systems (eQMS), with preference for QT9, and familiarity with stage-gate product development processes.
• Ability to thrive in a fast-paced, dynamic environment, manage multiple priorities, and work both independently and collaboratively across cross-functional teams.

Preferred

• Professional quality certifications such as ASQ Certified Quality Engineer (CQE), Six Sigma, or equivalent.
• Experience with semiconductor capital equipment, vacuum systems, or hazardous gas delivery systems.
• Knowledge of global regulatory and compliance requirements, including CE marking, RoHS, and REACH.

Other Requirements:

• Citizenship: RASIRC does not assume the responsibility to sponsor employees; this job requires US citizenship or a Permanent Resident Certificate (Green Card).

• Ability to stand for extended periods and perform repetitive tasks.

• Ability to lift and move up to 35 pounds.
• Must be willing and able to work in environments that require frequent bending, reaching, and lifting.
• Use of personal protective equipment (PPE) as required. Ability to work in an ISO Class 6 cleanroom with required cleanroom garb.
• This role requires working with dangerous and toxic liquids and gaseous chemicals and strictly following all safety protocols.

What We Offer:

• The salary range for this position is $100,000 - $130,000 year depending on experience and qualifications.
• RASIRC values employee growth and development and with that has a comprehensive training program to ensure that you reach the goals of your position, as well as provide the resources needed for your future career goals.
• Health and Wellness Benefits: RASIRC provides employer-paid medical coverage at 100% of the employee-only base plan and contributes 25% toward dependent coverage, with access to multiple plan options through a private exchange.
• Paid Time Off
• 401k with company match

How to Apply:

If you're ready to take on this exciting opportunity, please submit your resume and cover letter to https://rasirc.bamboohr.com/careers