Engineer I, QA (Marsiling)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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. DESCRIPTION: At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment. RESPONSIBILITIES: 1) Retrieve complaints from various database and update complaint log. 2) Review and process complaints in a uniform and timely manner. 3) Review technical complaint threshold report and initiate escalated complaint(s) from various databased into Trackwise System. 4) Lead in the resolution of customer complaint and quality issues on manufacturing floor to provide voice of customers to operations and translate customer's feedback into innovative solutions. 5) Participate in Product Qualification activities by reviewing test protocols and reports to ensure product quality meet the specified requirements. 6) Issue RMA (Return Material Authorization) for units that requires to be returned for FA (Failure Analysis) and ensure it returns for FA. 7) Perform failure analysis on product failures and work with Engineering to resolve product faults. 8) Establish DMRI (Device Master Record Index). 9) Review change orders, deviation, and pFMEA for products. 10) Provide COO (Country of Origin), COA (Certificate of Analysis), COC (Certificate of Conformance) upon request. 11) Provide management with quality data and trends in product performance in meeting customer requirements. 12) Act as Operation QA Representative for NPI (New Product Introduction) project and Transfer project. 13) Participate in quality initiatives program to address system inadequacies which may include quality programs, tracking, analyzing, reporting and problem solving to achieve continual quality improvement objectives. 14) Supports company goals and objectives, policies, and procedures in compliance with quality systems, cGMP and FDA regulations. 15) Ensure that systems and procedures are in compliance with ISO13485, MDSAP, FDA 21CFR Part 820, IVDR, ISO9001, ISO14001 and ISO45001 requirement. 16) Support plant-wide activities and special projects, as assigned. REQUIREMENTS: • Bachelor's Degree required, no prior experience required. Experience in pharmaceutical, medical device or life science industry preferred • Preferred Fields of Study: Mechanical or Electronics Engineering • Additional certifications in Quality Systems or GMP preferred • Knowledge of cGMP, ISO standards (13485/9001), and international regulatory requirements preferred • Good written and verbal communication skills • Able to work independently and collaborate effectively with cross-functional teams • Good computer skills including Microsoft Office applications