ProClinical is currently seeking a Quality System Manager for a global leader in medical technology. This leading medical device company is looking for a Quality Manager to lead the Quality System development and deployment in the Operations facilities. This is a permeant role based in Singapore.
- Ensures products manufactured meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements.
- Provides leadership and support for Customer Focused Quality, Quality Engineering and Quality System improvement initiatives.
- Function as the key regulatory contact for Manufacturing Operations.
- Leads the QMS function to ensure quality system development and compliance with FDA's Quality System Regulation, ISO 9001, ISO 13485/8, MDD, CMDR, Japan R-PAL and other quality requirements.
- Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
- Leads and/or supports initiatives to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality; supervise the Quality System Policy/Procedures Manual.
- Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
- Contributes quality expertise to product development and manufacturing transfers initiatives to ensure effective compliance to the Product Development Protocol and other applicable requirements.
- Oversees and lead key quality systems processes to ensure its effectiveness which includes Quality Planning, Document Controls, Training, Audits, Change Controls, Process and Software Validation, Non-conformance CAPA, Manage External Requirement, etc.
- Manages, conducts and coordinates external (FDA, TUV, etc.) audits.
- Manages the design and manufacturing documentation and traceability systems.
- Provides QA support, participate and collaborate in division related projects.
- Works with local management team members in developing long and short-term business goals and strategies.
- Representative at the Global Quality Leaders Council, collaborate with peers across all BUs for global quality initiatives and works closely with peers on similar quality concerns between MDT sites.
Skills and Requirements:
- Minimum of 6 management expertise in the Pharmaceutical, Medical Devices or any highly regulated manufacturing industry.
- Overall operational and financial acumen, Business and Project Management skills and experience a plus.
- Familiar with Quality System Regulation, MDD, and knowledge of Quality System Regulations and ISO.
- Training in the following will be advantaged:
- ISO 13485 Standards
- Basic Statistics
- Quality Auditing
- Continuous Quality Improvement Methods
- Effective interpersonal, communication and influencing skills
- Effective listening and writing/technical skills
- University or Master Degree in Engineering or Science with relevant experience
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 Vincent Ng on +65 6499 7148 or upload your resume 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.