Quality Systems Specialist

Description

The Quality Systems & Scientific Quality Specialist will serve as a technical quality resource responsible for supporting and improving Quality Management Systems, quality investigations, auditing, employee qualification, and continuous improvement within a highly technical manufacturing environment.

This role requires someone who approaches quality from an analytical and scientific perspective. The individual will evaluate quality data, investigate deviations and failures, identify root causes, assess product and process conformance, and translate findings into controlled procedures, corrective actions, and technical training.

The role is currently structured as an individual contributor position. However, the organization is open to expanding the scope for a candidate with previous Quality Manager or supervisory experience. A strong leadership candidate could potentially oversee approximately 45 Quality Technicians.

Quality Systems Support development, execution, and continuous improvement of the Quality Management System. Maintain quality procedures, specifications, SOPs, and controlled documentation. Ensure quality records are accurate, traceable, and audit-ready. Evaluate quality-system performance and identify opportunities for improvement. Maintain alignment with ISO 9001 and applicable customer requirements. Support additional laboratory-oriented standards such as ISO 17025 when applicable.

Quality Investigations & Root Cause Analysis Investigate product nonconformances, quality deviations, customer complaints, and returned materials. Evaluate available quality data to determine potential failure mechanisms. Perform or facilitate structured root cause investigations. Develop corrective and preventive actions. Assess corrective-action effectiveness after implementation. Partner with technical teams when investigation requires additional product testing or analysis.

Product & Process Quality Evaluate products and components against specifications and established acceptance criteria. Support investigation of inconsistencies in product performance, workmanship, or specifications. Review returned products and support RMA investigations through appropriate quality workflows. Partner with Quality Technicians to ensure inspection and testing activities are consistently performed. Identify trends that could indicate systemic quality problems.

Quality Data & Continuous Improvement Collect, review, and trend quality data.

Analyze:

Nonconformances Audit findings Customer returns Corrective actions Inspection results Training and qualification data Identify recurring trends and potential systemic failure mechanisms. Translate quality findings into measurable continuous improvement initiatives. Monitor results to determine whether improvements are scientifically and operationally effective.

Auditing & Compliance Develop and maintain internal audit schedules. Conduct QMS and process audits. Train internal auditors. Prepare technical documentation for customer and external audits. Document findings and ensure corrective actions are appropriately addressed. Analyze audit findings for broader trends rather than treating findings as isolated events.

Technical Training & Qualification This is not HR/L&D training. Training is directly connected to technical competency and quality. Develop technical training programs for Quality Technicians and other manufacturing personnel. Establish competency matrices and qualification requirements. Translate SOPs and quality procedures into effective hands-on training. Track certifications, qualifications, and recertification requirements. Evaluate whether training is producing consistent technical performance. Update training when investigations, audits, or quality trends indicate a knowledge gap.

Potential Scientific Quality Leadership

For candidates brought in at a manager level:

Lead approximately 45 Quality Technicians. Provide technical guidance for inspection, QC, and quality investigations. Review quality findings and determine appropriate escalation. Develop technicians' technical competencies. Assign quality priorities and ensure appropriate coverage. Serve as a technical escalation point between Quality leadership and frontline quality personnel.

Skills

qms, quality management system, quality assurance, auditing, root cause, capa, technical training, ISO9001, ISO17025, Metrology, technical leadership

Top Skills Details

qms,quality management system,quality assurance,auditing,root cause,capa,technical training

Additional Skills & Qualifications

Required

35+ years in:

Quality Assurance Quality Systems Quality Control Laboratory Quality Technical Compliance Related scientific/technical quality environment Strong QMS experience. ISO 9001 experience. Quality auditing experience. Root cause investigation experience. CAPA / corrective action experience. Strong documentation and data-integrity practices. Experience using quality data to make technical decisions. Experience developing or maintaining SOPs and controlled documentation. Scientific Backgrounds to Target

Recruiters should strongly consider candidates with backgrounds in:

Chemistry Biology / Biotechnology Materials Science Pharmaceutical Sciences Laboratory Sciences Quality Sciences Applied Sciences

Relevant technical experience may be more important than the exact degree.

Preferred Qualifications Experience within a large, mature quality organization Biotechnology Pharmaceutical manufacturing Aerospace Medical device Semiconductor Automotive Advanced materials Laboratory or analytical testing environments ISO 17025 experience Quality Manager or QA Manager experience Internal Auditor Certification Lean / Six Sigma training Previous leadership of QC/QA technicians

A Successful Candidate Will... Think like a quality scientist, not merely a document-control specialist. Ask why a failure occurred, not just whether the paperwork was completed. Be comfortable examining quality data and identifying patterns. Understand the relationship between product specifications, testing, process controls, and final product performance. Use root cause analysis and evidence to drive decisions. Bring technical credibility when working with Quality Technicians. Build scalable quality systems appropriate for a rapidly growing organization. Develop technical training that improves actual competency rather than simply checking a compliance box. Bring practices learned within a larger, established quality organization into a rapidly expanding team.

Experience Level

Entry Level

Job Type & LocationThis is a Contract position based out of Portland, OR. Pay and BenefitsThe pay range for this position is $37.00 - $47.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following:

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & LocationThis is a Contract position based out of Portland, OR. Application DeadlineThis position is anticipated to close on Nov 19, 2026. Workplace TypeThis is a fully onsite position in Portland,OR.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.