Product Quality Engineer – Medical Devices

Job Title: Product Quality Engineer – Medical Devices

Location: Remote (U.S.)

Employment Type: Contract (W2)

Duration: 6–12 months

Job Summary:

We are seeking a Product Quality Engineer with expertise in electrical failure analysis to support quality engineering activities for medical device products. The selected candidate will lead investigations into electrical product failures, perform root cause analysis, and collaborate with cross-functional teams to implement corrective and preventive actions that support product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.

Responsibilities:

• Lead investigations of electrical failure modes involving medical device field returns, customer complaints, and laboratory or manufacturing test failures.
• Conduct root cause analyses using structured methodologies such as 5-Why, Fishbone (Ishikawa), FMEA, and other problem-solving tools.
• Drive and support Corrective and Preventive Action (CAPA) activities related to electrical and electronic product issues.
• Partner with Design Engineering, Manufacturing Engineering, Quality, and other cross-functional teams to identify failure trends and implement effective corrective actions.
• Analyze product performance data and recommend improvements to enhance reliability and quality.
• Prepare clear technical documentation, investigation reports, and quality records in accordance with company procedures and regulatory requirements.
• Support compliance with applicable medical device quality standards and internal quality management system requirements.
• Participate in continuous improvement initiatives that enhance product quality and manufacturing processes.

Required Qualifications:

• Bachelor's degree in Electrical Engineering, Electronics Engineering, Biomedical Engineering, or a related technical discipline, or equivalent relevant experience.
• Demonstrated experience conducting electrical failure investigations and root cause analysis, preferably within the medical device industry or another regulated manufacturing environment.
• Strong understanding of electrical and electronic circuits, components, and common failure mechanisms.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, FMEA, CAPA, and quality system principles.
• Experience interpreting technical documentation, schematics, and engineering data.
• Strong analytical, problem-solving, communication, and documentation skills.
• Ability to work effectively in a collaborative, cross-functional environment.

Work Requirements:

• Must be legally authorized to work in the United States for the duration of the assignment.
• Ability to work remotely from an approved U.S. location while maintaining reliable internet connectivity.
• Ability to attend virtual meetings and collaborate across multiple time zones as needed.
• Occasional travel may be required based on business needs, if applicable.
• Reasonable accommodations will be provided for qualified individuals with disabilities in accordance with applicable law.

Salary/Rate:

$38.00–$40.00 per hour (W2 Contract)

This position offers a good-faith hourly pay range based on the anticipated responsibilities of the role, the candidate's qualifications, experience, skills, geographic location, and other business-related factors. Compensation may vary in accordance with applicable federal, state, and local laws.

Benefits:

This is a contract (W2) position. Employer-provided benefits are not applicable unless otherwise required by applicable law or specified in the employment agreement.

Equal Opportunity Employer:

We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, veteran status, military status, marital status, citizenship status where legally protected, or any other characteristic protected by applicable federal, state, or local law. Qualified applicants with arrest or conviction records will be considered in accordance with applicable law.

Application:

Qualified candidates are encouraged to apply by submitting a current resume highlighting relevant experience and qualifications. Applicants may request reasonable accommodations during the application or interview process as required by applicable law. Only candidates selected for further consideration will be contacted.