Senior Manager Quality Assurance
Singapore Singapore | Johor Bahru Malaysia
Responsibilities
Location Singapore, SG Job ID REQ-052633Responsibilities
- 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.
Basic Qualifications
- 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.
- Must communicate fluently in English and Mandarin.
Preferred Characteristics
- 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.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
