Engineer II, Quality

Job Description :

Work Schedule

Environmental Conditions

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.

DESCRIPTION:
Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.

RESPONSIBILITIES

Operations:

• Ensure incoming inspection, IPQC testing is performed timely to support array and instrument manufacturing.
• Ensure timely review and disposition of incoming inspection, IPQC batch records prior to release to QA.
• Ensure IPQC testing complies with ISO 13485 and other relevant regulated guidelines.
• Actively participate and contribute to PPI activities such as 5S, LEAN, JDI, VSM, RCCM and Kaizen improvements.
• Participate in method transfer and method validation activities for new products
• Provide timey updates on IPQC test results and participate in failure analysis to support array manufacturing process.
• Ensure junior staff are adequately trained to perform incoming inspection and IPQC testing
• Provide performance management, coaching and mentoring to junior staff as required.
• Support Quality Supervisor in accomplishing tasks as assigned

Sustaining:

• Ensure laboratory equipment is maintained according to established schedules.
• Manage laboratory inventory to support IPQC testing activities.
• Participate in the development of new testing procedures and assays to support the release of new products.
• Conduct investigation and trending analyses relating to incoming raw materials and reagents performance failures and identify and implement corrective and preventive actions (CAPA) as necessary.
• Support the NCM, RMA and QA operational activities to ensure timely closure
• Ensure training activities are completed and reviewed in a timely manner

QUALIFICATION

• Degree in biochemistry, life science, chemical engineering or equivalent.

EXPERIENCE AND COMPETENCIES REQUIRED

• Minimum 2 years QA/QC experience, preferably in medical device / biotech industries people management experience will be a plus
• Proficiency in handling analytical laboratory equipment like HPLC, FTIR and UV Vis Spectrophotometer.
• Proficiency in computer systems for laboratory test, analysis, and data management.
• Working knowledge of cGMP, IVDR and ISO 13485 compliance preferred.
• Strong written and verbal communications skills and demonstrated ability to work in a dynamic environment.
• Strong organizational skills and attention to details.
• Must be self-motivated, results oriented, and work well with minimal supervision.