Quality Engineer II

About the role

Location: San Diego, California. Duration: 7 Months.

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.

Requirements

• Education: Bachelor’s Degree (± 16 years) Engineering or Technical Field or equivalent experience; an equivalent combination of education and work experience; Master’s Degree (± 18 years) preferred.
• Experience/Background: 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.