Quality Specialist II, QS

Thermo Fisher Scientific • Los Angeles, CA

3d • $66,000 - $99,000 • Onsite

About The Position

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.

Requirements

• 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
• 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.

Nice To Haves

• Background in diagnostics or medical device manufacturing
• Experience with SAP and MasterControl systems
• Experience supporting GMP and ISO-regulated quality systems
• 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

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

Benefits

• 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
• Short- and long-term disability
• Competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level