Quality Specialist II, QS

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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.)

Job Description

• About Thermo Fisher Scientific

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