Engineer II, QA

at  Thermo Fisher Scientific

Are you an ambitious Engineer looking for an exceptional opportunity to make a significant impact? Thermo Fisher Scientific Inc. is seeking an Engineer II, QA with a proven track record of impactful work to join our world-class team. As a leading company in technological innovation, we are committed to enabling our customers to make the world healthier, cleaner, and safer.
This role supports our Distribution Center and is primarily office-based. Essential tasks include management of the Quality Management System (QMS), leadership of the site Quality Team, Change Control, Risk Assessments & Data Integrity.
In addition, the position holder will identify and recommend operational improvement opportunities and support leadership in achieving of business objectives.

Responsibilities:

• Responsible for Quality-related activities at the Greencastle, PA
• Improve all aspects of the QMS from planning to implementation on topics such as Distribution Quality Assurance, auditing, document management, CAPA resolution
• Drive continuous improvement across the Distribution Quality function, including a focus on reducing customer complaints.
• Develop and implement quality control procedures and standards
• Collaborate with diverse teams to ensure flawless execution of quality assurance processes
• Conduct thorough audits and inspections to identify areas for improvement
• Proactively identify and resolve quality issues, ensuring compliance with regulations and standards
• Participate in Customer/Internal audits
• Responsible for the Trackwise system – non-conformances, deviations, CAPA
• Provide Quality guidance to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs
• Lead the Change Control System and perform Risk Assessments
• Provide training and support to other departments within Distribution
• Work in a warehouse environment under various temperatures including room temperature, cold-room, and freezer-room.
• May be required to routinely push and pull and/or lift up to 40 lbs (20 kg).
• Perform other related duties as assigned

Requirements:

• Bachelor’s degree or equivalent experience in Engineering or a related field
• Minimum of 3 years of proven experience in Quality assurance
• Knowledge of regulatory guidelines: ISO13495, ISO9001
• Understanding of Distribution practices.
• Proven record of conducting Quality investigations including root cause analysis using Quality tools
• Strong analytical skills and attention to detail
• Excellent communication and collaboration skills
• Successful with influencing and getting results.
• Self-motivated with the ability to work as part of a team and/or independently

Join us in our United States location and be part of a company that values diversity and inclusion. Thermo Fisher Scientific Inc. is an equal opportunity employer, strictly adhering to EEO guidelines. We are committed to providing reasonable accommodations to job seekers with disabilities, ensuring equal opportunities for all. To apply and begin your journey with Thermo Fisher Scientific, please visit our website:

• Responsible for Quality-related activities at the Greencastle, PA
• Improve all aspects of the QMS from planning to implementation on topics such as Distribution Quality Assurance, auditing, document management, CAPA resolution
• Drive continuous improvement across the Distribution Quality function, including a focus on reducing customer complaints.
• Develop and implement quality control procedures and standards
• Collaborate with diverse teams to ensure flawless execution of quality assurance processes
• Conduct thorough audits and inspections to identify areas for improvement
• Proactively identify and resolve quality issues, ensuring compliance with regulations and standards
• Participate in Customer/Internal audits
• Responsible for the Trackwise system – non-conformances, deviations, CAPA
• Provide Quality guidance to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs
• Lead the Change Control System and perform Risk Assessments
• Provide training and support to other departments within Distribution
• Work in a warehouse environment under various temperatures including room temperature, cold-room, and freezer-room.
• May be required to routinely push and pull and/or lift up to 40 lbs (20 kg).
• Perform other related duties as assigne