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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 single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our company's Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement - eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location/Division Specific Information

Middletown, VA

Shift: Days

The Quality Specialist II will monitor/address/track quality issues that arise from Customer Complaints Inquiry,Non-Conformance (NCR) or from Internal/External quality system audits. This position will assist the Quality Manager and product line/QS process owners with Corrective/Preventive action (CAPA) projects to ensure timely and effective completion of required activities.

What will you do?

The duties and responsibilities include, but are not limited to, the following:

• The CAPA specialist progressed investigations through the CAPA system.
• Leads cross-functional teams to drive complex investigation closeouts, resolve root causes, and implement appropriate corrective and preventive action. Maintain and Improve Systems.
• Works to ensure that actions are on time, thorough, and complete, meet the business's and customers' needs, and that required standards and/or procedural requirements are met.
• Be an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with required regulations and compliance.
• Evaluate and progress the timely completion of CAPA system activities, including effectiveness checks raised for non-conformances, potential non-conformances, and/or deviations.
• Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
• Develop, maintain and monitor programs to be in compliance with the Quality Management System Regulations and internal procedures.
• Ensure completion and accuracy of all associated quality records related to nonconformance and CAPA reports.
• Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that aligns with Corporate and regulatory requirements.

• 2 years of experience in a Quality regulated environment
• Detailed knowledge of ISO and GMP regulations that govern medical device and diagnostics manufacturing.
• Investigational skills and Knowledge of CAPA requirements.

• Skilled in MS Word, Excel, and PowerPoint for presentations, spreadsheets, reports, and procedures.
• Lead meetings and obtain consensus among cross-functional teams
• Provide accurate QS tracking and trending reports.
• Good procedural writing skills a plus.