Summary
The Senior Manager, Quality Assurance is responsible for overseeing the Singapore site’s QMS as Site Quality Leader and Quality Management Representative. The position will provide guidance and support to the Singapore site’s quality team and will work closely with the Director of Quality, VP of Operations, and APAC regional business partners.
Key Accountabilities
- Appointed as the Singapore Quality Management Representative and Singapore Quality Site Leader for ISO 9001:2015 QMS.
- Ensure effectiveness and compliance to ISO 9001:2015 and various regulatory requirements as needed.
- Lead site quality team to drive operation and product quality improvements via data driven metrics.
- Oversee and support supplier quality, SCAR, product inspection, equipment calibration, CAPA, complaint investigation, change control, LMS training, and NPI activities.
- Chair quality management reviews and manage Internal & External audits.
- Support global quality system process integration, harmonization, and simplification. Managing local implementation and changes.
- Manage employee recruitment and development, performance management, and motivate team to achieve departmental objectives and goals.
- Escalate and manage any significant events such as safety, product shipping holds due to quality, regulatory, or any compliance issue.
- Lead or support identified special projects and key initiatives as needed.
- Work cross-functionally to achieve Singapore site objectives.
Requirements
- 8+ years of experience in Quality Management Systems within the medical device or pharmaceutical industry or under an ISO 13485:2016 or ISO 9001:2015 QMS.
- 5+ years of management experience.
- Knowledge of regulatory requirements and standards relevant to manufacturing such as (ISO45001/OHSAS18001 and ISO14001)
- Strong customer focus with complaint investigation, significant event reporting and CAPA skills.
- Internal Auditor certification.
- Strong data analysis skills and proficiency in electronic data management systems.
- Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.
- Ability to work independently and collaborate effectively with cross-functional teams.
- Proficiency in SAP, Microsoft Excel, Word, and PowerPoint.
