Quality Specialist III

Work Schedule

Standard (Mon-Fri)
Environmental Conditions
Office

Environmental Conditions

Location
This is a fully onsite role in Sunnyvale, CA with weekly travel to our San Jose, CA site.
Relocation assistance is not provided.

Keys to Success

• Education: Bachelor’s degree in Life Sciences, Engineering, Chemistry, Biology or related technical field with 5+ years of experience in quality assurance/quality control or Advanced degree with 3+ years of relevant experience
• Experience: Experience in regulated industries (pharmaceutical, medical device, or biotech preferred)
  Experience with quality management systems (TrackWise, Document Control Systems), CAPA processes, deviation management, and change control
  Demonstrated expertise in root cause analysis, investigation techniques, and corrective action implementation
  Experience conducting and hosting internal/external audits and regulatory inspections
  Proficiency in statistical analysis, data trending, and quality metrics reporting
  Project management experience preferred
• Knowledge, Skills, Abilities: Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements
  Knowledge of risk assessment methodologies and continuous improvement tools
  Strong technical writing skills for authoring SOPs, investigation reports, and other quality documentation
  Advanced problem-solving abilities and attention to detail
  Excellent verbal and written communication skills
  Strong interpersonal skills with ability to collaborate across functions and levels
  Ability to work in manufacturing environments with appropriate PPE as needed
  Ability to work independently and guide cross-functional teams

Compensation And Benefits

The salary range estimated for this position based in California is $90,900.00–$122,000.00.
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
• Retail 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