Quality Engineer

Highbrow Technology Inc; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

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

You will lead process control, CAPA, risk analysis, and use Six Sigma and Lean tools to improve product and process quality in a highly regulated medical device context.

Qualifications

• Minimum 2 years engineering experience with quality tools and methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, ISO 14971.
• Strong communication and leadership across multi-department teams.

Responsibilities

• Lead process control and CAPA systems to meet requirements.
• Design and conduct experiments for process optimization.
• Document experiment plans, reports and verification activities.
• Lead investigations and prevention of non-conformances.

Skills

Quality tools

Six Sigma

Lean Manufacturing

Project management

Statistical analysis

Communication skills

Leadership

Education

Engineering or Technical Field

Equivalent experience

Tools

ASQ CQE

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.

MAIN RESPONSIBILITIES

• Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Design and conduct experiments for process optimization and/or improvement
• Appropriately document experiment plans and results, including protocol writing and reports
• Lead process control and monitoring of CTQ parameters and specifications
• Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• Lead the investigation, resolution and prevention of product and process non-conformances
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
• Lead in the completion and maintenance of risk analysis
• Work with design engineering in the completion of product verification and validation
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

QUALIFICATIONS

Education

Education Level Major/Field of Study or Equivalent

years) Engineering or Technical Field or equivalent experience An equivalent combination of education and work experience

years) Preferred

Experience/Background

Experience Experience Details

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