Quality Engineer

Spectraforce Technologies; San Diego (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

Spectraforce Technologies in San Diego, CA seeks a Quality Engineer to develop and maintain quality methodologies across new product development, manufacturing, and support. You will lead process controls, CAPA, and QMS/EMS efforts while collaborating with design and microbiology teams.

Requirements include engineering experience with FDA/GMP/ISO standards, strong communication, and problem-solving skills. The role emphasizes quality systems and risk analysis in a fast-paced environment.

Qualifications

• Minimum 2 years of engineering experience with quality tools/methodologies (FDA, GMP, ISO 13485, ISO 14971).
• Strong communication and leadership for multi-department projects and quality issues.
• Advanced data analysis and report writing skills; prior medical device experience preferred.

Responsibilities

• Identify and implement process control systems for development and manufacturing.
• Lead in assuring process controls, CAPA, and quality systems to meet requirements.
• Assist in developing streamlined business systems to resolve quality issues.
• Apply systematic problem-solving to identify and resolve quality issues.
• Design and conduct experiments for process optimization and improvement.
• Document experiment plans, protocol writing, and reports.
• Lead CSTQ parameter monitoring and quality improvements like Six Sigma/Lean.
• Investigate and prevent product and process non-conformances.

Skills

Quality tools

Six Sigma

Lean Manufacturing

Project management

Statistical analysis

Cross-functional collaboration

Problem solving

Education

Bachelor's Degree in Engineering or Technical Field

Master's Degree Preferred

ASQ CQE or other certifications preferred

Tools

CAPA systems

Six Sigma

Lean Manufacturing

Job description

Position Title: Quality Engineer

Work Location: San Diego CA

Assignment Duration: 06 Months

Work Schedule: Will train on 1st shift for 2-3 months Then move to either 2nd shift at a 10% shift differential. Please submit at the 1st shift rate since they will initially be at 1st shift rates.

Main Purpose Of The Role

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 on-going 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.

Education?

• Education Level Major/Field of Study or EquivalentBachelors Degree Engineering or Technical Field or equivalent experience? An equivalent combination of education and work experience
• Masters Degree 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 well as attention to detail.