Quality Specialist II, QS

Work Schedule

First Shift (Days)

Environmental Conditions

Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while advancing solutions for some of the world’s toughest challenges.

Position Summary

The Quality Specialist II supports Quality Systems within a regulated medical device and diagnostics manufacturing environment. This role is responsible for monitoring, investigating, tracking, and resolving quality events including Nonconformances (NCRs), Deviations, Complaints, Supplier Corrective Action Requests (SCARs), and CAPAs.

The position partners cross-functionally with Manufacturing, Regulatory Affairs, Customer Service, Product Specialists, and Process Owners to ensure timely resolution of quality issues, effective product disposition decisions, audit readiness, and continuous compliance with ISO and GMP requirements.

Location : West Hills, CA. Relocation assistance is NOT provided.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

Key Responsibilities

Manage and support closure activities for NCRs, Deviations, Complaints, SCARs, and related quality records

Support escalation assessments for ISSUE/CAPA and Vigilance reporting requirements

Determine disposition and reconciliation of nonconforming materials, including quarantine and release activities

Conduct basic product reviews and failure analysis investigations

Review Device History Records (DHRs) and manufacturing documentation to identify potential quality anomalies

Gather and analyze information from cross-functional departments to support risk assessments and investigations

Ensure accuracy, completeness, and timely closure of quality system records

Support internal audits, external audits, and audit finding remediation activities

Participate in product-related meetings, quality reviews, and continuous improvement initiatives

Generate tracking, trending, and quality metrics reports using Quality Record Database and related systems

Participate in Gemba walkthroughs and escalate identified findings appropriately

Support SOP review, revision, training, and document control activities

Collaborate across departments to improve records management and quality system effectiveness

Provide additional Quality Management System (QMS) support as required

Minimum Qualifications

Bachelor’s degree in Biological Sciences or related scientific discipline

Minimum of 2 years of experience in a regulated quality environment within medical device, diagnostics, pharmaceutical, or biotech industries

Experience using Microsoft Office applications including Word, Excel, and PowerPoint

Preferred Qualifications

Background in diagnostics or medical device manufacturing

Experience with SAP and MasterControl systems

Experience supporting GMP and ISO-regulated quality systems

Knowledge, Skills & Abilities

Working knowledge of ISO standards and GMP regulations applicable to medical device and diagnostics manufacturing

Familiarity with CAPA systems, quality investigations, and statistical process control methodologies

Strong analytical, organizational, and problem-solving skills

Ability to generate accurate tracking, trending, and quality reports

Strong technical and procedural writing abilities

Ability to work independently and exercise sound judgment in decision-making

Effective verbal and written communication skills

Ability to build collaborative working relationships across functional teams

Ability to maintain confidentiality of sensitive information

Self-motivated with strong attention to detail and follow-through

Work Environment

Primarily office and manufacturing support environment

May require gowning and work within controlled manufacturing areas

Ability to perform computer-based work and data entry for extended periods

Occasional support during audits or operational escalations may be required

Compensation and Benefits

The salary range estimated for this position based in California is $66,000.00–$99,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards