Quality Engineer

AST; Washington (District of Columbia); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical (HSA & PPO)

Dental

Vision

HSA employer contribution

Disability insurance

401K with company match

Education Assistance

Paid Time Off

Paid Holidays

Bonus potential

Job summary

AST is seeking a Quality Engineer for a full-time, on-site role in Tacoma, WA to strengthen our ISO 9001 quality management system and support continuous improvement in aseptic manufacturing. You will collaborate with manufacturing and testing teams to ensure processes and products meet quality standards.

Key duties include maintaining QMS, leading NCR/CAPA activities, analyzing data for improvements, coordinating internal audits, and delivering training across the organization in a fast-paced

Qualifications

• Bachelor's degree in engineering or related field required.
• 5+ years of experience within a documented ISO Quality Management System.
• Experience with data analysis and MS Office/ERP systems.
• Familiarity with Six Sigma and LEAN methodologies.

Responsibilities

• Maintain the ISO 9001:2015 Quality Management System and ensure compliance.
• Execute the PCI (Continuous Improvement) program across the site.
• Provide guidance on industry standards and internal policies for compliance.
• Analyze data to identify quality improvements and drive actions.
• Coordinate and maintain Quality Management System programs.
• Ensure documentation supports internal audits and quality records.
• Interface with suppliers to uphold internal quality standards.
• Manage NCR/CAPAs and perform root-cause analysis.
• Develop and conduct quality training for all staff levels.
• Review project documentation for completeness against requirements.
• Create inspection plans using manual and CMM metrology equipment.
• Review drawings to ensure quality standards are met.
• Perform other duties as assigned.

Skills

Quality management

ISO 9001

Six Sigma

LEAN

Data analysis

ERP systems

MS Excel

Education

Bachelor's degree or higher in engineering related field

Tools

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 memberto 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 include:

• 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 QualityEngineer 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.

Key Responsibilities

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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.

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.

This is a full-time, on-site position based in Tacoma.

AST is an equal opportunity employer.