Quality Manager

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. Singapore
Posting date: 12 Mar 2019

ProClinical is recruiting for a Quality Assurance Manager position for an industry-leading manufacturer & distributor in specialist survival equipment solutions. This is a unique opportunity for an ambitious Quality Manager prepared to take on the challenge of management of the entire quality function of a company that introduces lifesaving products to an international and well-established customer base, predominantly in the Government/Public Sector. The incumbent would join the company's Singapore-based team.

The Quality Manager would be take on senior responsibility over the management of the specialist devices manufactured by the company.

Job Responsibilities:

  • Interacting directly with suppliers on quality-related matters.
  • Monitoring supplier quality performances, including on-time delivery and quality defects, and driving improvement activities by leading problem-solving meetings.
  • Interacting and communicating with program and functional areas to support the goals of the business.
  • Effectively communicating the requirements of the Quality Management System.
  • Conducting Quality Audits.
  • Investigation defects to identify and address the root cause.
  • Ensuring an effective and timely closure of actions that are received from Audit Non Conformities/internal Non Conformities/customer complaints.
  • Continuing awareness of external standards and regulatory requirements.
  • Ensuring that customer contractual requirements and Quality requirements are fully understood, met and flowed down to the required level, including suppliers/sub-contractors.
  • Participating in design reviews and performing First Article Reviews (FAR's), for both Internal and Supplier sources.
  • Evaluating product development, processes, and the performances of peer reviews of work products; supporting the implementation of program lifecycles and processes.
  • Maintaining quality records, including SCARS, 8D's, QCI and customer complaints.
  • Ensuring the integrity of products, materials and processes to satisfy business, customer and regulatory requirements.
  • Generating, reviewing and maintaining Quality/Supplier Quality/Configuration Management Plans.
  • Independently test witnessing/First Article Reports, both on site and at suppliers.
  • Applying statistical techniques that support effective process management.
  • Applying quality tools and techniques that facilitate the monitoring, reporting and resolution of quality issues.
  • Applying risk management techniques to asses, mitigate and prevent potential product quality issues.
  • Occasionally travelling internationally to supplier sites.

Skills and Requirements:

  • A bachelor's degree, or equivalent experience in an Engineering/Quality Assurance discipline.
  • Comprehensive experience of working with Medical Device/IVD regulated products, with knowledge of ISO13485 / FDA QSR Part 820.
  • Demonstrable experience of completing audits with Regulatory/Certification Bodies.
  • Comprehensive knowledge, and the ability to facilitate and perform complex Root Cause, Preventative Counter Measure and Corrective Action implementation.
  • Previous experience conducting supplier assessments.
  • Excellent verbal and written English.
  • Excellent IT skills.
  • Demonstrable knowledge and ability to perform predictive statistical data analysis.
  • Excellent interpersonal, communicative and costumer focused mindset.
  • Previous project management experience.
  • The ability to work in a time sensitive environment, and the ability to work both collaboratively and autonomously on your own initiative.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Julie Yuan on +6531591345 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.