Quality Systems Specialist

1 week ago

Singapore eTeam Full time

Overview

Assoc Specialist, Quality Systems — Role Purpose: Perform quality operations as per transition service agreement to maintain compliance of regional regulatory requirements.

Key Responsibilities

  • Warehouse Quality Management: Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, and Returned Products; maintain compliance of country specific labeling process; implement and track Quality Hold (Global & local) in 3PL; drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements; drive and execute rework activities; initiate and track internal complaints resulting from labeling and other regulatory non-compliance; perform first article inspection (FAI) for product distributed in Asia Pacific & greater China region; ensure implementation of company’s procedure/work instruction in warehouse; manage and follow up SCARs.
  • Act as quality engineer for Asia Pacific labeling and other quality documentation.
  • Supplier quality: maintain existing supplier and support in new supplier qualification; provide Quality Training to suppliers.
  • Post Market Quality Assurance: oversight and maintain compliance of Product Complaint Handling Process in APAC (including receiving and reporting complaints to CH Center, following up complaint investigation, sample return, etc.).
  • Execute Field Corrective Action Process including operations in JDE system. Act as Local FCA Coordinator for Region.
  • Generate quality system reports and perform trend analysis.
  • Maintain training compliance for region.
  • Participate on audit teams by responding and gathering data to address audit requests.
  • Own and manage NCR, CAPA, PRA in region.
  • Assess the impact of quality systems information (e.g., Enterprise Change Requests (ECRs), CAPA) and provide feedback to originators.
  • Other incidental duties.

Education/Experience (Required)

  • Bachelor’s degree in related field
  • 3 years of previous experience in quality and/or manufacturing environment in the medical device industry

What else we look for (Preferred)

  • Good written and verbal communication skills and interpersonal relationship skills
  • Good problem-solving and critical thinking skills
  • Good knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems
  • Good knowledge of medical or pharmaceutical regulations as relating to documentation
  • Good understanding of medical devices regulations (e.g. ISO13485)
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Seniority level

  • Mid-Senior level

Employment type

  • Contract

Job function

  • Health Care Provider and Manufacturing

Industries

  • Medical Equipment Manufacturing
  • Pharmaceutical Manufacturing
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