Quality Engineer

Highbrow Technology Inc; San Diego (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Highbrow Technology Inc. seeks a Quality Engineer to develop and maintain quality engineering methodologies and provide QA support across new product development, manufacturing, or system/services support.

The role emphasizes FDA/GMP/ISO 13485/ISO 14971 knowledge, Six Sigma/Lean experience, and strong communication within a matrixed, fast-paced environment.

Qualifications

• 2–5 years of engineering experience with quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485 and ISO 14971.
• Strong communication and interpersonal skills.
• Project management and leadership for multi-department teams.
• Experience with Six Sigma and Lean manufacturing.
• ASQ CQE or other certifications preferred.
• Experience in a matrixed, cross-divisional business environment.
• Ability to work as a team member and individual contributor.
• Excellent organizational and follow-up skills.

Responsibilities

• Develop and maintain quality engineering methodologies.
• Provide quality engineering support across NPD, manufacturing, and services.

Skills

Quality tools

Project management

Communication skills

Data analysis

Lean/Six Sigma

Cross-functional leadership

Medical device experience

FDA/GMP/ISO knowledge

ADR problem solving

Job description

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

• Minimum 2 years 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Solid communication and interpersonal skills.
• Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills Prior medical device experience preferred.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.