Engineer II, QA

Life Technologies - Bridgewater Township, NJ

Full-time - Mid Level

Bridgewater Township, NJ

Miscellaneous Manufacturing

About the position

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. In the role of Quality Engineer II, you will support quality aspects of high-throughput filling and warehousing on day-to-day operations and on continuous improvements. Your primary focus will be to increase product quality and customer satisfaction through effective application and improvement of the established quality management system and through systematic monitoring and analysis of identified quality indicators. Your responsibilities will include documenting and triaging customer complaints, identifying and documenting internal nonconformances and deviations, performing impact assessments, and identifying root causes using various root cause analysis tools. You will also initiate Corrective and Preventative Actions (CAPA) as appropriate, make disposition decisions, and facilitate the disposition process. Leading critical in-process inspections or reworks will be part of your daily tasks, along with developing and maintaining effective relationships and integrating activities with other departments. Participation in gemba and supporting continual improvements will be essential, as will maintaining metrics in line with key performance indicators and ensuring compliance with ISO 9001:2015 and other regulatory requirements. You will also participate in audits and inspections to support internal activities and act as the site authority in the electronic investigation tracking system.

Responsibilities

• Document and triage customer complaints.
• Identify and document internal nonconformances and deviations.
• Perform impact assessments and identify root causes using various root cause analysis tools.
• Initiate Corrective and Preventative Actions (CAPA) as appropriate.
• Make disposition decisions and facilitate the disposition process.
• Lead critical in-process inspections or reworks.
• Develop and maintain effective relationships and integrate activities with other departments.
• Participate in gemba and support continual improvements.
• Maintain metrics in line with key performance indicators.
• Ensure compliance to ISO 9001:2015 and other regulatory requirements.
• Participate in audits and inspections to support internal activities.
• Act as site authority in electronic investigation tracking system.

Requirements

• Bachelor's degree from an accredited college/university or equivalent experience; Science or Engineering Degree preferred.
• High school diploma or equivalent required.
• Minimum of 3 years of relevant Quality, Manufacturing, or Engineering experience in a regulated industry.
• Proven track record of collaborating in multi-functional teams.
• Demonstrated ability to conduct quality investigations including root cause countermeasure.
• Experience developing Corrective and Preventative actions.
• Strong verbal and written communication skills in English.
• Knowledge of Quality standards (e.g. ISO 9001:2015).

Nice-to-haves

• Knowledge of Global Systems e.g. Trackwise, Oracle Cloud eDMS is considered a plus.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Outstanding career and development prospects
• Innovative and forward-thinking organization
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.