Senior Engineer, Design Quality - Life Sciences MNC

Job description

Our client is a well-known manufacturer of Life Sciences equipment

Responsibilities:

• Participate in new product development initiatives by providing quality engineering support to assigned projects.

• Oversee the Product Development Process and ensure defendable practices and scientific analyses are employed.

• Provide QA oversight on software, hardware and consumable development process throughout the life-cycle of projects to ensure adherence to procedures as required by QMS.

• Collaborate with the software development team to ensure that verification and validation activities are complete and robust

• Perform document review and approval of software, hardware and consumables engineering documentation (e.g. System Requirements Specifications, Design and Development documentation, Verification and Validation Test plans/ procedures /final reports)

• Review and maintain Design History Files and ensure they comply with company procedures and regulatory requirements.

• Participate in Design Transfer activities.

• Participate in supplier selection from design perspective.

• Participate in product Risk Reviews during product development and post-launch activities.

• Maintain product Risk Management files.

• Develop NPI Quality Plans.

• Perform review and approval of Engineering Change Request and Engineering Change Orders.

• Oversee quality procedures for the software, hardware and consumable functions within the Product Development group.

• Lead process definition and improvement activities and training within the software, hardware and consumable functions.

• Provide QA oversight on non-product software validation and perform document review and approval of non-product software validation documentation (e.g. Validation Plan, protocols, Validation Reports)

• Work with the QMS team to improve awareness, communication, and training on quality procedures and initiatives to support corporate quality goals as a leader in Mass Spectrometry as well as an emerging medical device company.

• Provide data analysis & trending of processes & products characteristics and other feedback on current product issues to the development team.

• Participate in continuous improvement activities in a cross-functional environment (e.g. Kaizen).

• Member of internal audit team and to lead internal audit teams.

• Mentor and coach individuals and teams while resolving problems and implementing best practices.

• Maintain and comply with the requirements of ISO9001, ISO13485, FDA 21 CFR Part 820 and other applicable regulatory requirements.

• Supporting Role - Quality Management System (QMS)

  • Identify areas for improvement of the QMS through active participation in internal audit program.

  • Schedule and support audit activities including pre-audit planning, audit readiness and post-audit follow-up with lead auditor.

  • Support the development and administration of the complaints handling, CAPA and internal non-conformance processes.

  • Provide training on basic quality tools to the supporting functions.

  • Ensure compliance of operations within areas of concern with all relevant EHS regulatory requirements and Company safety policies, procedures and guidelines.

Requirements:

• Bachelor’s degree in engineering or equivalent.

• A minimum of 5 years of related experience in a manufacturing environment especially instruments manufacturing with focus on

  • New product development

  • Design changes

  • Design transfer

• Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS, ISO 14971 Application of Risk Management to Medical Devices and FDA 21 CFR Part 820 is strongly desirable.

• Exposure to/ experience with verification & validation of medical devices

• Ability to read technical drawings and experience in writing procedures to QMS requirements.

• Excellent writing and oral communication skills with the ability to effectively interface with a variety of associates at various levels.

• Systematic problem-solving skills in identifying, prioritizing, communicating, and resolving quality issues.

• High attention to detail and processes

• Strong organization and multi-tasking skills

• Goal oriented, interpersonal, self-motivated and team player

• Knowledge of MS Office (Word, Excel) and other quality tools (Minitab, FMEA, SPC, DOE, etc.) and their application.

• Certification in Six Sigma green/ black belt is an advantage.

Please contact Ewen Poh at +65 6950 0365 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.