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 & Location
This is a Contract position based out of Portland, OR.
Pay and Benefits
The 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 & Location
This is a Contract position based out of Portland, OR.
Application Deadline
This position is anticipated to close on Nov 19, 2026.
Workplace Type
This 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 [email protected] 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.