Job Abstract

Job Description

Position Summary:

Quality Specialist III, Post Market Surveillance (PMS) and Stability will provide support in preparation of data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews and review and closure of certain categories of complaints. It requires regulatory assessment capability along with MDR/Vigilance reporting. The specialist may also review and monitor data and document quality, as requested by the manager.

Key Responsibilities:

Product Complaints:

• The duties and responsibilities include, but are not limited to the following:
• Review and analyze lot documentation (DHR’s) to resolve if there are any anomalies that may have related to reported product failures.
• Perform basic product review and failure analysis.
• Prepare risk management plan, facilitate risk analysis and assessment per Risk Management Policy, monitoring and compiling data from adverse events, customer inquiries, complaint records, CAPAs, deviation reports, stability reporting, non-conformance reports, PERs, PCRs, recalls, scientific literature searches, clinical performance, and proficiency testing.

Product Stability:

• Coordinates and performs various stability testing in accordance with stability protocols.
• Ensures stability samples are available and placed in stability chambers at the appropriate time frames to meet the requirements of the stability protocol.
• Ensures stability samples are pulled at the appropriate time frames to meet requirements of the stability protocol.
• Analyzes stability test data using the department stability software program.
• Assists Risk and PMS manager with summarizing stability data for submission into the final stability report.
• Ensures testing and data analysis is completed in a timely manner to meet business and regulatory timelines.
• Identifies Out of Specification results and notifies manager in a timely manner.
• Notifies manager immediately when adverse stability data trends are identified.
• Ensures stability chambers are maintained and calibrated according to internal and external quality and regulatory requirements.

Product Development Risk Review:

• Document and facilitate product development and change risk reviews.
• Assist with Post Market Surveillance department functions as needed. (Specific requirements may vary and will be documented in department records, job assignments and/or project action items).
• Perform computer operations for data entry and provide tracing/trending reports. Abide by corporate policies, procedures and work instructions.
• Assist during FDA, ISO or other third party or internal audits. Other duties as assigned.

Minimum Requirements:

• Bachelor’s degree in Biological Sciences or a related field.
• 3 years of experience in a Quality regulated environment.
• Able to create presentations, work with spreadsheets, prepare reports and write procedures using MS Word, Excel and PowerPoint software applications.

Preferred Qualifications:

• Background in diagnostics.

Knowledge of:

• Detailed knowledge of ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing. Knowledge of complaint handling requirements.
• Trending tools and reporting techniques.

Ability to:

• Lead meetings and obtain consensus among cross functional teams.
• Provide accurate QS tracking and trending reports. 
• Good procedural writing skills a plus. 
• Exercise independent discretion and judgment in execution of duties. 
• Plan and organize oneself in a consistent manner. 
• Be a self-starter with the ability to positively motivate others in a collaborative fashion. 
• Establish and maintain effective collaborations staff members. 
• Effectively communicate both orally and in writing to management, customers and regulatory personnel. 
• Maintain confidentiality of laboratory information; perform computer operations for data entry.

Compensation and Benefits

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