Quality Engineer II

Abbott; San Diego (CA); On-site; USD 85,000 - 105,000; Part time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

401(k)

Job summary

Abbott in San Diego, CA is seeking a Quality Engineer II for a 7-month, 100% onsite assignment. Shifts are 3PM to 11:30PM. The role focuses on establishing effective process controls, CAPA systems, and quality assurance across development and manufacturing.

You will lead Six Sigma/Lean improvements, risk analysis, and cross-functional collaboration with Design, Microbiology, and QA teams. The position requires 2–5 years of engineering experience with strong knowledge of FDA regulations and ISO

Qualifications

• Bachelor's degree in Engineering or technical field or equivalent experience.
• Master's degree preferred.
• 2-5 years engineering experience with quality tools/methodologies.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971 is required or preferred.

Responsibilities

• Identify and implement process control systems for development, qualification, and manufacturing of products.
• Lead assurance, process controls, CAPA systems.
• Develop and execute streamlined business systems to identify and resolve quality issues.
• Design and conduct experiments for process optimization and improvement.
• Document experiment plans, protocols, and results.
• Lead CTQ monitoring and product/process improvements (Six Sigma/Lean).
• Investigate, resolve, and prevent non-conformances.
• Collaborate with design engineering and microbiology on product verification/validation.

Skills

Quality tools / methodologies

Statistical data analysis

Project management

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in Engineering or technical field

Master's degree

Job description

Title: Quality Engineer II

Location: San Diego, California

Duration: 7 Months

Shifts: 3PM TO 11:30PM

100% Onsite

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

• Bachelors Degree (± 16 years) Engineering or Technical Field or equivalent experience An equivalent combination of education and work experience
• Masters 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.

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.