Quality Engineer II

Akkodis; San Diego (CA); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401K plan

Job summary

Akkodis is seeking a Quality Engineer II for a 6-month onsite contract in San Diego, CA 92121. The role focuses on developing and maintaining quality engineering methodologies, providing QA support across NPD, manufacturing, and service activities.

The candidate will lead process controls, CAPA, and Six Sigma/Lean initiatives while ensuring regulatory compliance with FDA, GMP, ISO standards. Equal opportunity employer with comprehensive benefits.

Qualifications

• Bachelor's Degree in Engineering or technical field required.
• 2+ years of quality engineering experience preferred, with FDA/GMP/ISO knowledge.
• ASQ CQE or similar certification preferred.

Responsibilities

• Identify and implement process control systems for development and manufacturing to meet requirements.
• Lead CAPA and assurance initiatives to meet internal/external standards.
• Document experiments, protocol writing, and results; lead risk analysis.

Skills

Quality engineering

CAPA

Six Sigma

Lean Manufacturing

Regulatory knowledge

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

ASQ CQE

Job description

Akkodis is seeking a Quality Engineer II for a 06-month contract with a client in San Diego CA 92121- Onsite.

Title: Quality Engineer II

Contract: 06 months with possible extension

Pay Rate: $40/hr. - $45/hr. (The rate may be negotiable based on experience, education, geographic location, and other factors)

Summary

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. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

• 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.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

The California Fair Chance Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers