Associate Manager-Quality Assurance, ASEAN in Singapore at Stryker Corporation

Date Posted: 11/24/2020

Job Snapshot

Job Description

Who we want

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

  • Ensure compliance to the corporate and regulatory requirement, such as GDPMD and ISO 13485 and any local regulation pertaining to quality management system.
  • Lead or support the project or any initiative related to quality management system improvement and quality awareness in ASEAN.
  • Manage the document control process and maintain the procedure up to date to current practice
  • Lead, manage and coordinate internal, 3PL/4PL, distributor and external audits on ASEAN’s QMS, e.g. annual ISO 13485 audits and GDPMD(S) audits. Work with other departments to ensure success of QMS implementation. Follow up for any corrective action/ preventive action.
  • Lead and manage all government Safety Alerts, Field Safety Corrective Actions/Product field actions, Product Holds, Product Complaints and Adverse Event Reporting in ASEAN with the local teams and manufacturing divisions to ensure timely initiation and closures per internal and regulatory deadlines.
  • Manage Field Safety Corrective Actions/Product field actions and Adverse Event/Problem Reporting to local government authorities in ASEAN per regulatory requirements, format and timelines.
  • Perform role as CQDC reviewer for ASEAN/ East Asia on Wind-chill, and assessing the gaps between existing Quality Management System (QMS) in place and propose drafts to QA East Asia to meet corporate and latest/prevailing regulatory requirements.
  • Monitor, consolidate and report key quality matrices (KQM), highlights report to corporate for ASEAN
  • To coordinate, prepare and sharing the Management Review for ASEAN in frequently basis.
  • Provide QA training to new staff or refreshers for existing staff., new or existing dealer or distributor Develop training materials and programs with manager on various effective platforms/channels.
  • Participate in local/industry, regional/international, corporate initiatives and project groups related to post-market activities (PFA/PH/complaints), QMS, Quality, quality charters.
  • Be the Trackwise trained trainer and superuser/admin for ASEAN.
  • Provide timely and regular updates to management on changes in regulations related to quality/ post-market requirements in ASEAN. Identify any gaps and risks early and propose strategies to supervisor and management.
  • Represent ASEAN on the Global project or Quality Council, collaborate with peers across international market and division for any quality initiative and implement the project to Stryker ASEAN.
  • Any other quality and regulatory related project.

Key talents /strengths for the role:

  • Possess cross-cultural sensitivity
  • Excellent communicator and influencing skills
  • Able to work cross-functionally with different stakeholders in the company to drive desired outcomes
  • Independent and self-driven, has initiative
  • Achiever and Timely
  • Integrity and Compliant

What you need

Minimum bachelor’s degree in pharmacy, biomedical sciences or related

Prior experience in QMS management

Certified internal auditor for ISO 13485 and/ or GDPMD

Minimum 8-10 years exp in Medical Devices, preferable in the Sales/Distribution Environment

Operational and Financial acumen, business and Project Management Skills and experience is a plus

Work From Home: Occasional

Travel Percentage: 20%

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