Senior Quality Assurance Engineer

2 weeks ago

Fremont, California, United States Maxonic Full time

Maxonic is committed to fostering enduring partnerships with our esteemed clients. To address their requirements, we are in search of a Senior Quality Assurance Engineer.

Position Overview:

Job Title: Senior Quality Assurance Engineer

Job Type: Long-term Contract (Potential for Extension and Transition to Full-time)

Location: Remote

Compensation: Competitive Hourly Rate + Benefits

Work Schedule: Monday to Friday (40 hours/week)

Key Responsibilities:

As a Senior Quality Assurance Engineer, you will:


• Develop, execute, and assess testing strategies and protocols to guarantee that medical device products comply with all quality benchmarks.


• Supervise product quality throughout the entire lifecycle of product design and development.


• Collaborate closely with research and development teams to facilitate new product initiatives and enhance product designs.


• Investigate quality discrepancies and recommend necessary modifications.


• Operate under general guidance while exercising independent judgment.


• Consult with internal stakeholders on specific projects as needed.


• Lead and support new product development projects, ensuring compliance with internal quality management systems and relevant regulations.


• Ensure that appropriate design controls are in place during design evaluations.


• Provide insights to operations regarding quality concerns, including process enhancements and updates to risk assessments.


• Oversee pre- and post-production quality assurance activities related to product lifecycle development.


• Review and endorse validation protocols and reports, collaborating with Supplier Quality and Supply Chain teams to ensure effective supplier development.


• Confirm that configuration management and risk analysis documentation are accurately maintained.


• Evaluate testing protocols and final reports for thoroughness and precision.


• Ensure that design modifications are processed in accordance with established change-control protocols.


• Manage and complete assigned tasks within designated timelines, identifying and proposing solutions for any issues that may impact project schedules.


• Provide quality engineering support for investigations as necessary.


• Coordinate the resolution of potential quality assurance issues identified during the product realization phase.


• Lead and assist in corrective and preventive action (CAPA) investigations, reviews, approvals, and implementations as required.

Required Qualifications:


• Bachelor's degree with a minimum of 7 years of experience in medical device quality assurance.


• Strong interpersonal skills and the ability to work collaboratively, fostering a professional atmosphere and cooperative relationships within the team and across departments.


• Proven experience in product and process validation, software validation, test method validation, statistical analysis, risk management tools, and process control.


• Ability to analyze trends and data, translating findings into actionable improvements.


• Excellent documentation skills, with a strong focus on process orientation and meticulous attention to detail.


• Strong verbal and written communication abilities.


• Self-motivated and independent thinker, capable of working autonomously.


• Proficiency in Microsoft Office Suite.


• Quality engineering certification (ASQ CQE or CQA) is preferred.


• Familiarity with lean six sigma manufacturing methodologies.


• Additional training in lean processes, such as green belt certification, is a plus.

About Maxonic:

Since its inception, Maxonic has excelled in aligning candidate capabilities with client needs. Our award-winning team of dedicated recruiting professionals specializes in various technologies, actively listening to candidates to find positions that align with their long-term career aspirations. We take pride in our successful placements and the lasting relationships we build with our clients.

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