Quality Systems Specialist

Integrated Resources Inc.; Seattle (WA); On-site; USD 60,000 - 85,000; Full time

Job summary

A leading company in workforce solutions is seeking a Quality Systems Specialist. This role involves managing quality processes, improving compliance in manufacturing, and supporting audits. Ideal candidates will have a strong background in quality assurance with excellent communication and analytical skills. The position is crucial for ensuring product quality and regulatory compliance.

Qualifications

• Minimum of 2 years in Quality Assurance, preferably in electronic manufacturing.
• Experience with ISO 9001 and/or ISO 13485 preferred.
• Ability to work independently.

Responsibilities

• Assist in the definition and maintenance of quality processes.
• Coordinate annual calibration activities.
• Lead internal audits of quality processes.

Skills

Detail-oriented

Problem-solving

Relationship building

Analytical skills

Excellent written communication

Excellent oral communication

Data analysis

Education

Associates Degree in related science or business

Bachelor of Science degree in related science or business

Tools

Microsoft Office

Job description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

The Quality Systems Specialist will assist with planning, implementing, and sustaining a site-wide quality management program.

Essential Functions

• Quality Management System Support: Assist in the definition, implementation, and maintenance of quality processes and procedures supporting business and regulatory needs.

• Support Corrective and Preventative Action Program (CAPA) – Identify problems, establish effective corrective actions, and work with others to resolve problems.

• Document Control – Assist with management of document control processes.

• Assist with administering and expanding site training program, including collection and organization of training records.

• Coordinate completion of annual calibration activities.

• Assist with regulatory technical file maintenance: RoHS Certificates, REACH, etc.

• Participate in the investigation of customer complaints. Review and approve complaint records.

• Test and inspect product at specified stages in the manufacturing process to ensure compliance with specifications.

• Support incoming quality inspection program (non-conformance disposition, return of material to suppliers, tracking supplier performance).

• Provide guidance to document authors to ensure accuracy, correctness and consistency.

• Lead internal audits of quality processes such as Document Control, Training, CAPA, Deviation, etc. to ensure site procedures are followed.

• Support internal and external audits.

• Assist with generating monthly metrics for divisional and corporate leadership.

Required Skills & Abilities:

• Detail-oriented and a creative problem-solver.

• Strong relationship building skills.

• Excellent written and oral communication skills.

• Ability to learn specialized databases and software systems

• Ability to work independently, with minimal supervision

• Strong Microsoft Office computer skills, and experience working with data analysis and problem solving tools.

• Excellent analytical skills. Able to use data to identify trends and understand problems.

Preferred Skills & Abilities:

• Working knowledge of ISO 9001 and/or ISO 13485 requirements

• Experience working in an electronic manufacturing environment

• Bill of Material (BOM) maintenance and review experience

• Experience participating as part of an audit team

Qualifications

Education and Experience Required:

• Minimum Associates Degree in related science or business, with minimum two (2) years of Quality Assurance preferably in an electronic manufacturing environment.

• Bachelor of Science degree in related science or business; or

• Any combination of education and experience that provides the same expertise.