Quality Engineer Cooler Heads San Diego, CA Job Details Full-time $85,000 - $105,000 a year 17 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Parental leave Qualifications Teamwork Content creation for technical audiences Technical documentation Technical writing experience within manufacturing Production validation processes Quality risk management Attention to detail Requirements analysis Quality inspection Software development Regulatory/legal compliance standards in production Design controls Biomedical regulatory compliance Quality audits Test validation method

ISO 13485

Cross-functional communication Full Job Description Job Summary Seeking a Quality Engineer to supports design quality, quality systems, regulatory documentation, and manufacturing activities within the medical device industry. Working cross-functionally, the Quality Engineer helps ensure regulatory compliance, supports product development, maintains technical documentation, and drives continuous improvement in a regulated environment. Principal Responsibilities Design Quality

• Support design reviews, technical documentation, and risk management activities (e.g., FMEA).
• Collaborate with R D to define product requirements and acceptance criteria.
• Prepare, execute, and document design verification and validation protocols and reports.
• Support intended use validations and computer system validation activities. Quality Systems
• Draft, revise, and maintain SOPs, work instructions and quality records.
• Support quality metrics, complaint investigations, nonconformances, CAPAs, and internal audits.
• Assist with root cause analysis and continuous improvement initiatives. Regulatory
• Support regulatory submissions including 510(k), Letter to File and product labeling.
• Assess product changes for quality and regulatory impact.
• Maintain compliance with applicable FDA requirements, ISO 13485, ISO 14971, IEC 62304. Production Quality
• Support supplier qualification, supplier quality issues, and corrective actions.
• Develop and maintain inspection plans and acceptance criteria. Support manufacturing investigations, equipment qualification, and process validation activities (IQ/OQ/PQ). Essential Requirements
• Bachelor's degree in engineering or related technical field.
• 2-4 years of quality engineering or quality assurance experience in the medical device industry.
• Working knowledge of

FDA QMSR, ISO

13485, risk management per ISO 14971, software development lifecycle.

• Familiarity with design controls, verification and validation, and quality system processes.
• Strong technical writing, problem-solving, and organizational skills.
• Ability to collaborate effectively across cross-functional teams. Desired Skills
• Experience supporting 510(k) submissions or EU MDR technical documentation.
• Familiarity with startup or fast-paced product development environments.
• Familiarity with supplier quality, process validation, and CAPA.
• Strong technical writing skills and attention to detail. Personal Attributes
• Strategic thinker with strong hands-on execution and problem-solving skills.
• Comfortable working in a fast-paced, high-growth environment with evolving priorities.
• Excellent communicator with strong interpersonal, collaboration, and influencing skills.
• Collaborative, adaptable, and mission-driven, with a proactive approach to continuous improvement.
• Takes ownership of assigned tasks, follows through on commitments, and is accountable for delivering high-quality results.

Pay:

$85,000.00 - $105,000.00 per year

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Health savings account Paid time off Parental leave

Work Location:

Hybrid remote in San Diego, CA 92111