Quality Manager, Distribution Centre, APAC

Permanent Position
27 Apr 2017
Expires on 11 May 2017

Company Description

Our client is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.

Posted by

Kelvin PANG Yu Kiu (Reg No: R1325516)

Tel

+65 9712 3229

Email

Job Description

  • Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
  • Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve manufacturing processes/methods (including evaluation of source materials and suppliers) and based on engineering principles; analyze results, make recommendations, and develop reports
  • Identify and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.  Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc., to improve manufacturing processes, and reduce risk
  • Develop, update, and maintain technical content of risk management files
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
  • Lead Auditor regarding quality compliance audit of 3PLs as well as suppliers and Distributors and monitor status and progress of Supplier Corrective Actions
  • Execute quality release of material, products and returns
  • Other duties as assigned by Management

Requirements

  • Bachelor’s degree or related degree in an engineering or scientific field required – preferably in medical expertise and Quality Management. An advanced degree (i.e. Master, PhD) is most preferred
  • Minimum of 10 years relevant working experience with 5 years professional experience in Quality Management in a medical or pharmaceutical Quality environment. Experience of working with US companies/exposure to US environment. Preferably with some experience working in a manufacturing site and handling lab/industrial equipment
  • Good leadership, project management, risk management, analytical and communication skills
  • Excellent understanding of Quality Systems and national regulatory requirements is required
  • Good knowledge in ISO 13485, 21 CFR 820, 21 CFR 11, relevant regulatory requirements in country, and all other applicable requirements. Certified ISO lead audit is preferred
  • Experience handling FDA Inspection / Local Inspection preferred
  • Good knowledge in process validation, risk management and statistical techniques
  • Good knowledge and understanding of Engineering principles, theories and concepts
  • Good organization and analytical abilities, ability to interact effectively with all levels of staff, stable personality and high sense of responsibility, professional image and work ethic
  • Ability to work effectively with diverse cultures and able to promote information across functional areas both within the candidate’s region and globally
  • Ability to work in a team environment, including inter-departmental teams between plants and key contact personnel representing the organization on contracts or projects
  • Ability to make tough and difficult decisions and to drive implications with integrity and consistency
  • Resiliency to adapt to change and implement changes rapidly, always seeking continuous innovation and improvement
  • Exceptional ability to rank strategic and operational choices – willing and able to be hands-on and hard working
  • Ability to work under pressure and manage competing priorities in a fast-paced environment
  • Proficient in PC skills required
  • Excellent proefficieny in spoken/writen English required

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