Senior Quality Engineer at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

08 Jan, 26

Salary

0.0

Posted On

10 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Data Analysis, Process Improvement, Audits, Compliance, Change Management, Statistical Controls, Communication, Interpersonal Skills, Internal Auditor, Lead Auditor, Risk Management, SOP Construction, Corrective Actions, Preventive Actions, Quality Management System

Industry

Biotechnology Research

Description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Quality Initiatives and Continuous Improvement: Lead the development and implementation of quality initiatives to address system inadequacies as well as to achieve continual quality improvement objectives. Drive continuous improvement projects through Practical Process Improvement to ensure the timely and accurate completion of quality projects and tasks. Work with management to devise and implement quality strategies and policies. Audits and Compliance: Manage internal audits by plan and coordinate to ensure the internal audit findings are rectified and corrective action is implemented. Support external audits and follow up on external audit findings and corrective actions. Ensure quality systems and procedures are in compliance with ISO 13485, MDSAP, FDA 21 CFR Part 820 IVDR, IVDR Quality Management and Data Analysis: Provide management with quality data and trends in product performance in meeting customer requirements. Review customer complaints and analyze data for trends. Identify quality issues through data and trend analysis, work with relevant functions on corrective and preventive actions. Review deviation and risk management for products Quality Assurance and Change Management: Participate in the construction of SOPs, review and approve of COs (Change Order) on changes that affect the quality management system. Support organization in change management which includes QMS and new product release and changes based on approved and released documentation as defined in respective processes, SOP and project responsibilities. Support and Special Projects: Support plant-wide activities and special projects, as assigned. Qualification Bachelor degree in Science, engineering or equivalent. Experiences Minium 5 years in QA function with people management Relevant working experience in quality function dealing with medical devices / IVD devices / ISO13485 environment preferred Competencies Preferred Proactive and assertive attitude. Ability to interface effectively in a global matrix organization environment Strong communication (verbal and written) and good interpersonal skills with all levels. Trained as internal auditor and lead auditor. Knowledge of statistical controls and data analysis Experience in Process validation activities as Quality function Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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Responsibilities

Lead the development and implementation of quality initiatives to address system inadequacies and achieve continual quality improvement objectives. Manage internal audits and ensure compliance with quality systems and procedures.