about the company
Our client is a global biotechnology leader in the field of mass spectrometry and capillary electrophoresis. They’re a manufacturer of analytical instruments and solutions provider for precision detection. They’re on a look out for a highly committed Senior Supplier Quality Manager to oversee the Supplier Quality Engineer (SQE) team.
What you will be here for
- Responsible for leading globally responsible teams that oversee Supplier qualification and oversight, Supplier Corrective Action Request (SCAR) program and Supplier qualification quality records
- Responsible for developing a high-performing supplier quality team
- Responsible for implementing the Supplier Management Process in accordance with ISO 9001, ISO 13485 and US 21 CFR 820 across multiple global sites.
- Responsible for the supplier audit program development
- Responsible for investigating supplier quality issues to determine root cause and implement corrective actions
- Responsible for participating in the process for new supplier selection and working with suppliers to improve their quality and capability. Deploy supplier and contract manufacturer quality management strategies.
- Define and manage assurance strategies to reduce part “dead on arrival” (DoA) events at manufacturing and customer sites.
- Establishes escalation channels at suppliers and contract manufacturers
- Oversees Supplier Quality Key Performance Indicators and associated operating mechanisms, problem-solving when necessary.
- Serves as the process Subject Matter Expert (SME) during internal and external audits (Quality System Registrars, Regulatory agencies, customers, etc.)
- Provides input and recommendations for the identification and selection of improvement projects throughout the organization.
- Collaborates across the organization at all levels, across functional groups and geographic locations
- Communicates regularly with executive management, users and staff on the quality status of suppliers and ongoing problem resolution
What you will need
- Bachelor's degree in engineering with min 5 years experience in Supplier Quality Engineering or similar engineering field
- Min 3 years experience in people management, including ability to manage remote regional teams
- Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDR, ISO 13485, ISO 9001
- Knowledge of quality system management principles and regulatory requirements for medical devices with the ability to train others.
- Good knowledge of production techniques and processes required
- Professional designations not required but training and certification in quality or regulatory affairs are a plus (e.g. CQM, CQE, CQA, RAC, Six sigma, Lean)
If you are interested in the position, kindly send your CVs to yiling.tan(@)randstad.com.sg.
Please include your availability, expected salary and reason for leaving your current job.
We regret that only shortlisted candidates will be contacted.
Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
EA: 94C3609 / Reg: R21103172...