Quality Engineer

Akkodis; San Diego (CA); On-site; USD 59,000 - 62,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Short-term disability

401K plan

Paid leave

Job summary

Akkodis is seeking a Quality Engineer in San Diego, CA 92121 (Onsite). The ideal candidate has 2+ years of engineering experience with quality tools and methodologies, and knowledge of FDA, GMP, ISO 13485, ISO 14971.

Strong communication and leadership skills are required, with experience in Six Sigma and Lean Manufacturing. Responsibilities include implementing process controls, CAPA systems, and leading cross‑functional teams to meet internal and external requirements.

Qualifications

• Minimum 2 years (2–5 years) 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 skills, including the ability to lead cross‑functional project teams and resolve quality issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing; prior medical device experience preferred.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

Responsibilities

• Identify and implement effective process control systems to support development, qualification, and ongoing manufacturing of products.
• Lead in the implementation of assurances, process controls, and CAPA systems.
• Assist in developing and executing streamlined business systems to identify and resolve quality issues.
• Apply sound, systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Design and conduct experiments for process optimization and/or improvement.
• Document experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of CTQ parameters and specifications.

Skills

Problem solving

Statistical analysis

Data analysis

Communication

Leadership

Job description

Akkodis is seeking Quality Engineer in San Diego CA 92121(Onsite). Ideally Looking for someone Minimum 2 years 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies.

Pay Range: $43/hour - $45/hour. on w2 The rate may be negotiable based on experience, education, geographic location, and other factors.

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.

Qualifications:

• 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).

If you have questions about the position, please contact Mohammed Irfan Murtuza at [e-mail]

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