Quality Engineer

automatedsystemsoftacoma; Tacoma (WA); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical (HSA & PPO)

Paid Dental

Vision

401(K) with company match

Paid Time Off (PTO)

Bonus potential

Job summary

automatedsystemsoftacoma is seeking a Quality Engineer to ensure the efficiency and compliance of their Quality Management System. This role involves collaborating across teams, analyzing quality data, and managing corrective actions.

The ideal candidate will hold a Bachelor’s degree in an engineering field and have over 5 years of experience within an ISO Quality Management System. The position offers competitive compensation and a range of benefits including medical, dental, and 401K options.

Qualifications

• 5+ years of experience within an ISO Quality Management System.
• Experience in equipment and software verification and validation.
• Ability to take initiative and work autonomously.

Responsibilities

• Maintain ISO 9001:2015 Quality Management System.
• Develop quality procedures and perform audits.
• Analyze company data to provide quality recommendations.

Skills

ISO 9001:2015 Quality Management System

Microsoft Excel

Six Sigma certification

LEAN methodology

Statistical analysis

Education

Bachelor’s degree in engineering or related field

Tools

MS Office

ERP Systems

CMM metrology equipment

Job description

At AST, we enhance the efficiency, productivity, and safety of flexible aseptic manufacturing processes for the worldwide Life Science Industry by offering innovative products, services, and solutions.

Do you want to contribute to a shared vision and mission? Would you like to bring your unique talents to have a significant impact on a growing company? At AST we strive to build a workplace that enables every team member to meet and exceed their capabilities. We set our expectations high and provide the environment and resources necessary to bring out the very best.

Competitive compensation range for onsite WA applicants is $95,000 to $125,000. All applicants are welcome to apply.

Employee Benefits

• Medical (HSA & PPO)
• Paid Dental
• Vision
• HSA account with employer contribution (eligible the first of the month following your date of hire)
• Long/Short term disability
• 401(K) (Traditional & Roth options) with up to 5% company match (eligible 90 days after date of hire)
• Education Assistance
• Paid Time Off (PTO)
• Paid Holiday
• Bonus potential

All benefits on this page are subject to change.

What can I expect in this role?

The Quality Engineer will support AST by ensuring the overall efficiency and effectiveness of the AST Quality Management System. This includes ensuring products and processes meet quality standards by working with manufacturing and assembly personnel, testing, and analyzing defects. Responsibilities include collaborating with other teams, developing quality procedures, performing audits, and developing corrective actions for implementation.

Key Responsibilities

• Maintain the ISO 9001:2015 Quality Management System and ensure compliance.
• Execute the company wide Process of Continuous Improvement (PCI).
• Provide assistance and guidance to company in interpreting industry standards and internal policies to ensure compliance.
• Analyze and interpret company data to provide recommendations relating to quality within the company.
• Coordinate and maintain all aspects of the company’s Quality Management System programs.
• Ensure documentation is completed and made available to demonstrate internal compliance, including quality manuals and plans, certifications, work instructions, and records for internal audits.
• Interface with key suppliers to maintain internal quality standards.
• Manage the Non-Conformance (NCR) / Corrective Action (CAPA) processes and coordinate root cause analysis.
• Develop and conduct Quality training for all levels of employees.
• Review project documentation to ensure completeness with internal and customer requirements.
• Create and implement inspection plans using manual and CMM metrology equipment.
• Review and interpret engineering drawings to ensure internal and external quality standards are met.
• Perform other duties as assigned.
• Expected travel: <15%

Qualifications

• Bachelor’s degree or higher in engineering related field.
• 5+ years of experience working within a documented ISO Quality Management System.
• Skilled in the use of computer software for analysis of data; preferably Microsoft Excel, Access, and statistical packages.
• Experience with GAMP or similar standards for equipment and software verification, validation testing, and documentation.
• Training with certification in Six Sigma and LEAN.
• Proficient with MS Office and ERP Systems.
• Experience with identifying and implementing improvements to manufacturing processes.
• Ability to embrace a fast-paced culture.
• Ability to be self-driven, take initiative, and work autonomously to achieve KPI’s.
• Lead with a results-driven mindset, reinforcing accountability to achieve and exceed metrics.
• Excellent verbal, written, and presentation communication skills.

Eligibility Requirements

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take and successfully pass a drug test.
• Must be willing to submit to and successfully pass a background check.

AST is proud of our team. Providing challenging and rewarding work, with opportunities for personal/professional development is our key to this longevity. Compensation is competitive, including salary, bonus potential, health plan options, competitive 401K match, and paid time off.

This is a full-time position based in Tacoma.

AST is an equal opportunity employer.