Medical Device Quality Assurance Specialist

3 days ago

Singapore HOYA MEDICAL SINGAPORE PTE. LTD. Full time
HOYA Medical Singapore PTE. LTD.

About Us

As the globally leading Preloaded Intraocular Lens (IOL) focused company, HOYA Surgical Optics (HSO) provides innovative technologies and solutions to exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. Our commitment is grounded upon a quality management system that continuously improves to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

We aim to create a conducive work environment for our employees around the globe, promoting an inclusive culture based on our core values – Excellence, PASSION, Innovative, Collaboration, and Accountability.

Our Way of Working

  • We are Accountable for our own capabilities and development,
  • Focused on delivering results without excuses, and
  • Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

About the Role

This position plays a crucial role in ensuring products meet quality goals and regulatory requirements, including FDA Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971. The successful candidate will maintain compliance of the Quality Management System (QMS).

Responsibilities

  • The Quality Assurance Specialist will partner with R&D teams in the USA, Japan, and Singapore to ensure design control is completed in accordance with procedures, WI, regulatory requirements, and assure that required outputs have been completed.
  • They will execute risk management for devices, processes, and provide the assessment results from product development through to the launch.
  • Maintaining and updating risk management files with Global R&D/Manufacturing Engineering (ME) teams to support product development (Risk Management Plans, Risk Control Log, Benefit Risk Assessment Risk Management Report, xFMEA, etc.) is also part of the job.
  • The Quality Assurance Specialist will assist in the review and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports, and design transfer.
  • Reviewing and approving design verification test protocols, reports and data from a logical point of view (Compliance, rationale, objectiveness and statistics)
  • Partnering within Quality and R&D to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met.
  • Reviewing and approving biocompatibility protocols and reports
  • Ensuring compliance of IQ, OQ, tests method validation, Standard Operating procedures and work instructions regarding product development
  • Maintaining compliance to QMS procedures of the R&D Singapore site, and supporting the Singapore R&D Site - QA
  • Sometimes they may need to support External audits by competent authorities and notified bodies
  • Sometimes they may need to support internal audits at the local site, and other sites as required
  • Reviewing and approving other quality documents (e.g., IQ, OQ, PQ, WI, etc) within areas of responsibility
  • Proposing and executing quality/process improvements. Writing/reviewing policies/ processes/ procedures and related documents
  • Managing and monitoring the progress of the calibration and maintenance of testing equipment. Ensuring calibration or maintenance records satisfy regulatory and QMS requirements (act as Equipment Control Administrator in Singapore)
  • Participating in development projects and change control request meetings to support the resolution of engineering issues
  • Collaborating with the post-market surveillance team and complaints investigation teams to maintain risk management process throughout a product's lifecycle
  • Providing support for other quality activities and improvement initiatives, quality data collection and trending, CAPAs, change controls, training, etc.
  • Supporting initiatives as identified by management to support QMS and other regulatory requirements in Singapore

Requirements

Experience:

  • At least 4+ years of Industry experience working as QE Engineer in Medical Device/ Pharmaceutical product or optical engineering business field
  • Experience in test method validation
  • Experience in Design control, Design Transfer, Design and Development Process
  • Demonstrated knowledge of Risk Management (ISO14971), Design control, Design and Development Process and Quality System (any one of ISO13485).
  • Understanding and Knowledge of biocompatibility studies
  • Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
  • Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management
  • Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
  • Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
  • Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required
  • Capable of clearly presenting and justifying quality requirements to management
  • Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)

Salary Range: SGD $60,000 - SGD $80,000 per annum

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