Total 2,427 reservoir engineer job vacancies in Quality Assurance / Control category in Singapore

Responsibilities

• Coordinate with classification society and Brazilian regulatory compliance consultants to achieve the required project deliverables related to classification and regulatory compliance.
• Coordinate and manage FPSO and Project regulatory requirement stemming from regulatory bodies (Authorities, Flag State, Class, etc)
• Lead, coordinate and manage the execution of the Regulatory Compliance Matrix, and other deliverables for FPSO Project.
• Point of contact with project disciplines, Class and Flag state representatives and surveyors while executing Regulatory Compliance Matrix (Class, Flag and Brazilian Regulations).
• Communicate with project team and instill awareness of regulatory requirement.
• Interface with project team, client, Class and authorities during execution of the Regulatory Compliance Plan and Matrix.
• Work with project team to deliver a regulatory-compliant FPSO and ensure Project complies to all applicable regulatory requirement.
• Facilitate the review, identification, and implementation of regulatory requirements along with Classification society and Brazilian Regulatory consultant for inclusion into project design, specification, and project activities.
• Check that documents and reports are in compliance with Brazilian requirements.
• Support the compilation and handover of Dossiers to the FPSO owner.
• Interface with authorities, project disciplines/functions and client reps for acquisition of permits, licenses and consents as needed.
• Establish vendor scope of works for authorities-related approvals, activities and inspections.
• Initiate preparation of all Class-required Manuals and Plans as per regulatory compliance matrix
• Formulate and record Flag state exemption applications and Class Rule deviation applications.
• Champion/expedite closure of Open Class/authorities/Brazilian regulatory comments (Technical and Survey) comments.

Requirements

• Bachelor’s degree in Mechanical, Offshore and Marine Engineering/ or related engineering disciplines
• Minimum 3 years of working experience in regulatory compliance management with good understanding of Brazilian Regulatory requirements in oil and gas projects
• Familiar with terms and standards used in the marine and/or offshore industry
• Good proficiency in English (written and spoken)
• Advanced user of Microsoft Office products
• Some working knowledge and experience in site inspection standards, class rules requirements and industry codes on hull and structure in marine operations (i.e.SOLAS, MARPOL, IMO MODU Code, API Standards and ISO Standards)
• Experience in the design compliance and risk analysis studies in the projects

Our Address and work hours

Seatrium Limited

Tuas Yard

51 Pioneer Sector 1, Singapore 628437

(Islandwide transport provided)

Mon - Fri: 7:30am - 4:30pm/ 6:30pm

Interested candidates are invited to send us an updated resume with your current and expected salary and earliest availability.

We regret that only shortlisted candidates will be notified.

Please note that your personal data disclosed to Seatrium Limited and our group of companies, shall be used for the purposes of evaluation, and processing in accordance with our recruitment processes and policies. By providing your personal data, you have consented to the aforesaid purpose under the provisions of the Personal Data Protection Act 2012.

Introduction

Nextkidney SG is a subsidiary of Nextkidney, a Dutch medical technology company based in Singapore. We are focused on the development of sorbent based dialysate regenerative device for use in a portable hemodialysis device. Our vision is to be the global leader in making portable dialysis affordable and accessible to all.

Learn more about us at www.nextkidney.com

Job description

Nextkidney SG is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team as QA Engineer. As part of the R&D team , you will influence the development of a new generation of home hemodialysis device, as it transitions from design to mass production.

Responsibilities:

1. QMS Management:

• Oversee and maintain the Quality Management System (QMS) to ensure compliance with regulatory standards, including ISO 13485 and 21 CFR 820.
• Develop, implement, and maintain quality policies, procedures, and processes to support the QMS.

2. Regulatory Compliance:

• Stay abreast of industry regulations and standards related to medical devices (eg, EU MDR, FDA regulations and relevant standards).
• Work closely with regulatory affairs to ensure products meet all necessary regulatory requirements.
• Assist in preparation and consolidation of technical documentation needed for both manufacturing transfer and regulatory submission.

3. Process Improvement:

• Identify areas for process improvement within the QMS and collaborate with cross-functional teams to implement changes.
• Facilitate investigation and root cause analysis of non-conformities and documentation and implementation of CAPA.
• Conduct internal audits to assess and improve compliance with established processes.

4. Risk Management:

• Participate in risk management activities for medical devices, including risk assessments, mitigation strategies, and documentation.

5. Documentation and Reporting:

• Manage the creation, review, and approval of quality-related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
• Generate reports on key quality metrics and present findings to management.

6. Training:

• Provide training and orientation to employees on quality processes and procedures to ensure a thorough understanding of QMS requirements.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Quality Assurance, Engineering, Biology, etc.).
• Proven experience in Quality Assurance within the medical device industry.
• In-depth knowledge of ISO 13485, FDA regulations, and other relevant standards.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with a commitment to maintaining high-quality standards.
• Certification in Quality Management (e.g., ASQ Certified Quality Engineer) is a plus.

Come join our team! Please reply with your resume and expected salary