Non-Invasive Therapy Devices QA Analyst – Los Angeles, CA

Are you passionate about ensuring product quality and safety in the rapidly evolving medical device industry? We are seeking a Quality Assurance (QA) Analyst to support the development and compliance of non-invasive therapy devices in Los Angeles, CA. This is a critical opportunity to contribute to the delivery of safe, effective, and innovative healthcare solutions. If you have a keen eye for detail, a strong understanding of FDA regulations, and a commitment to quality excellence, we want to hear from you.

Join a Leading Medical Technology Team in Los Angeles

A cutting-edge medical device company in Los Angeles, CA is looking for a dedicated QA Analyst to support its growing portfolio of non-invasive therapy devices. The ideal candidate will bring experience in medical device quality systems, validation protocols, and regulatory documentation. This role offers the chance to be part of a collaborative team focused on improving patient outcomes through safe and reliable technologies. If you’re ready to play a pivotal role in quality assurance and regulatory success, this is the position for you.

Key Responsibilities of the Non-Invasive Therapy Devices QA Analyst – Los Angeles, CA

Quality System Management: Support the maintenance and continuous improvement of the company’s Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory standards. Ensure documentation accuracy, version control, and system audits are up to date.

Product Testing & Validation: Collaborate with engineering and R&D teams to develop and execute test protocols, verification and validation (V&V) activities, and ensure product quality from development through production stages. Analyze test results and document findings to ensure consistent product performance and safety.

Regulatory Documentation: Prepare and review Device Master Records (DMRs), Design History Files (DHFs), and Technical Files for regulatory submissions. Assist in compiling accurate and audit-ready documentation for FDA inspections, ISO audits, and internal quality reviews.

Non-Conformance & CAPA Management: Investigate non-conformances, perform root cause analysis, and contribute to the development and implementation of effective Corrective and Preventive Actions (CAPAs). Monitor trends and work proactively to reduce product and process deviations.

Supplier Quality Assurance: Support supplier audits and incoming inspection processes to ensure materials and components meet quality standards. Collaborate with procurement and external partners to resolve quality issues and maintain approved supplier lists.

Internal Auditing & Compliance: Conduct internal audits across departments to verify compliance with established processes and regulatory requirements. Document findings, recommend improvements, and track corrective actions to closure.

Training & Documentation Control: Assist in the creation and delivery of QA-related training for internal teams. Maintain proper documentation practices, update standard operating procedures (SOPs), and ensure employee awareness of quality policies.

Risk Management: Participate in risk analysis activities such as FMEA (Failure Modes and Effects Analysis) and contribute to the risk management file throughout the product lifecycle. Ensure all risks are documented, mitigated, and managed according to regulatory expectations.

Continuous Improvement: Identify opportunities for process optimization and quality enhancements. Contribute to a culture of continuous improvement through participation in cross-functional initiatives, quality meetings, and feedback loops.

Collaboration & Communication: Act as a liaison between QA, engineering, manufacturing, and regulatory teams to ensure alignment on quality objectives and project timelines. Communicate clearly and effectively to support product launches and compliance milestones.

What the Client is Looking for in You

As a Non-Invasive Therapy Devices QA Analyst, the client is seeking a detail-oriented quality professional with a strong background in medical device quality systems and regulatory compliance. You should have a passion for ensuring product safety, reliability, and effectiveness through rigorous quality processes. This role is ideal for someone who thrives in a highly regulated, fast-paced environment and is committed to upholding the highest quality standards.

Medical Device Quality Experience

The client is looking for a candidate with hands-on experience in the medical device industry, preferably with Class II or Class III devices. You should be well-versed in FDA regulations, ISO 13485 standards, and other applicable quality and regulatory requirements. Familiarity with verification and validation processes, documentation controls, and risk management tools such as FMEA is critical.

Strong Attention to Detail and Analytical Thinking

Success in this role requires an analytical mindset and a methodical approach to problem-solving. The ideal candidate will have demonstrated the ability to identify and investigate non-conformances, contribute to root cause analysis, and support CAPA implementation. Accuracy in documentation, data analysis, and compliance reporting is essential.

Commitment to Compliance and Continuous Improvement

The client values a QA Analyst who is proactive about maintaining compliance and continuously improving quality systems. You should have experience conducting internal audits, supporting external inspections, and implementing changes that enhance efficiency and compliance across departments.

Collaborative Communication Skills

As part of a cross-functional team, you will need excellent communication and interpersonal skills to work effectively with engineering, manufacturing, and regulatory colleagues. The ideal candidate is a strong team player who can clearly articulate quality requirements, provide constructive feedback, and support shared project goals.

Technical Proficiency and Documentation Expertise

You should be confident using quality management software, maintaining Design History Files (DHFs), and preparing documentation for regulatory audits and submissions. Experience with electronic document management systems (EDMS), statistical process control, and quality data tracking tools is highly valued.

Customer and Product Safety Focus

Above all, the client is looking for a QA Analyst who understands the critical role of quality in protecting patients and end-users. A strong sense of responsibility, ethics, and commitment to product safety and performance is non-negotiable in this role.

FAQs About the Role – Non-Invasive Therapy Devices QA Analyst – Los Angeles, CA

1. What are the key responsibilities of the QA Analyst in this role?
As a QA Analyst, you will be responsible for ensuring the quality and regulatory compliance of non-invasive therapy devices. This includes executing test protocols, reviewing documentation, participating in internal audits, supporting CAPA activities, and working cross-functionally to uphold product and process quality standards. You will also help maintain the company’s QMS in accordance with FDA and ISO 13485 regulations.

2. What qualifications and experience are required for this position?
The ideal candidate should have a degree in engineering, life sciences, or a related technical field, along with experience in a QA role within the medical device industry. Knowledge of FDA regulations, ISO 13485 standards, and risk management processes such as FMEA is required. Experience with Class II or III medical devices, electronic documentation systems, and internal auditing is preferred.

3. What skills are essential for success in this QA Analyst role?
Attention to detail, analytical thinking, and a solid understanding of quality principles are critical. You should be comfortable interpreting technical documents, managing quality records, and working collaboratively with engineering and regulatory teams. Strong communication skills, problem-solving ability, and adaptability in a regulated environment are also essential.

4. What challenges can I expect in this role?
You may face challenges such as ensuring ongoing compliance in a dynamic regulatory landscape, resolving quality issues quickly, and supporting tight deadlines during product development or audits. Balancing documentation accuracy with efficiency and cross-functional coordination will also be key aspects of this role.

5. How does this role impact the company’s success?
As a QA Analyst, you play a critical role in ensuring patient safety and maintaining product reliability. Your work supports successful regulatory submissions, smooth manufacturing processes, and customer satisfaction. Your contributions help prevent costly recalls or non-compliance issues, directly influencing the company’s reputation and success.

6. What is the team environment like?
The company offers a collaborative, quality-driven environment where innovation and compliance go hand in hand. You’ll work with professionals across engineering, regulatory, and operations teams. Continuous improvement, mutual support, and a focus on professional growth are key aspects of the team culture.

What Remuneration Can You Expect from This Job?

As a Non-Invasive Therapy Devices QA Analyst in Los Angeles, CA, you can expect a competitive compensation package that reflects the technical expertise, regulatory knowledge, and quality assurance responsibilities required in the medical device industry. The remuneration typically includes the following:

1. Base Salary

The base salary for a QA Analyst in the medical device sector generally ranges between $70,000 and $100,000 annually, depending on experience, education, and specific responsibilities. Professionals with strong regulatory and industry expertise may command higher salaries within this range.

2. Performance-Based Bonuses

Many employers offer annual performance bonuses based on individual performance, team contributions, and company-wide goals such as audit outcomes, regulatory milestones, or product launch success. Bonuses typically range from 5% to 15% of the base salary.

3. Health & Wellness Benefits

You can expect a comprehensive benefits package, which may include:

Medical, dental, and vision insurance
Health Savings Account (HSA) or Flexible Spending Account (FSA) options
Mental health support and employee wellness programs
Short-term and long-term disability coverage

4. Retirement & Financial Plans

Most companies offer structured retirement plans such as:

401(k) plans with employer matching contributions
Employee stock purchase plans (if applicable)
Financial planning and education resources

5. Paid Time Off (PTO) & Leave Policies

Typical PTO packages include:

2–3 weeks of vacation per year
Sick leave and personal days
Paid company holidays
Maternity/paternity leave or family care leave, where applicable

6. Additional Perks

Depending on the employer, you may also receive:

Continuing education and professional development reimbursement
Access to training programs or certifications
Remote or hybrid work flexibility
Commuter benefits or relocation assistance

Total Compensation Summary

When combining base salary, bonuses, benefits, and perks, the total annual compensation for a QA Analyst in this field typically falls between $85,000 and $120,000, with growth potential based on performance and promotion to senior QA or regulatory roles.

How to Apply

If you are a detail-oriented and proactive Quality Assurance professional with a passion for advancing healthcare through innovative medical devices, we encourage you to apply for the QA Analyst – Non-Invasive Therapy Devices role based in Los Angeles, CA.

This is a critical opportunity to contribute to the safety, quality, and regulatory compliance of cutting-edge therapy devices that improve patient outcomes. You’ll work closely with cross-functional teams to ensure product reliability, lead QA initiatives, and support FDA and ISO regulatory requirements.

To apply, please submit the following:

Your updated resume showcasing your quality assurance experience in medical device or life sciences sectors
A cover letter detailing your hands-on experience with QA processes, documentation systems, internal audits, validation protocols, and regulatory compliance (e.g., ISO 13485, FDA 21 CFR Part 820)
Any relevant certifications (such as ASQ, Six Sigma, or internal auditor training)

This role offers a rewarding opportunity to make a real impact in healthcare quality, advance your QA career, and join a collaborative, mission-driven team in a thriving medical technology environment.

Apply now to be considered for the QA Analyst – Non-Invasive Therapy Devices position in Los Angeles, CA, and help shape the future of non-invasive medical innovation.

For more information or to discover related roles, visit our Medical Device & QA Careers Page.

Job Category: Medical Device

Job Type: Full Time

Job Location: Los Angeles

Non-Invasive Therapy Devices QA Analyst – Los Angeles, CA