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
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 ResponsibilitiesManage 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 QualificationsBachelor’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 QualificationsBackground in diagnostics or medical device manufacturing
Experience with SAP and MasterControl systems
Experience supporting GMP and ISO-regulated quality systems
Knowledge, Skills & AbilitiesWorking 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 EnvironmentPrimarily 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
