Senior QA Manager
Salary Market Aligned
Consultant LeeLing Lim
Job Ref 1856240/001
Date posted 24 October 2022penang mining-engineering-operations/quality-assurance 2022-10-24 2022-12-23 manufacturing-and-production Penang MY Robert Walters https://www.robertwalters.com.my https://www.robertwalters.com.my/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
An exciting Senior QA Manager job has become available at one of the world’s prominent medical device manufacturers focusing on manufacturing and production operation management in a new establishment in Penang. Reporting to the VP of Quality Assurance, this opportunity for a candidate who is passionate about driving the organisation to greater heights and participating their business expansions.
About the Senior QA Manager Role:
The Senior QA Manager job scope includes a wide range of responsibilities leading the end-to-end quality engineering with experiences to lead, manage and strategise all quality aspects; ISO13485/QSR, Process Validation, Risk Management, DMR, Customer Complaint, Internal/External Audit, Product Release and Regulatory Compliance matters.
- Maintain and improve the effectiveness of QMS (ISO13485:2016/QSR Part 820)
- Manage internal audit, customer audit, CB audit and FDA audit
- Review and approve procedures
- Review and approve NC and CAPA reports
- Lead monthly/quarterly quality objectives review meeting and management review meetings
- Monitor customer feedback and improvement
- Report overall plant quality status to the top management and global QARA team
- Manage QA budget and expenses
- Participate in hiring and coaching QA personnel
To succeed in this role, you must have in-depth knowledge of QMS, ability to handle a high-mix, low-volume manufacturing environment.
- Bachelor’s degree in engineering or business, master's degree is preferred
- Minimum of 10 years of related experience in quality and/or manufacturing in full spectrum quality engineering
- At least five years in management and working with quality management systems
- Experience in ISO13485 and FDA requirements is a must
- Reads, writes, and understands specifications, inspection criteria, schematics and mechanical drawings
- Knowledge of techniques like six sigma, lean manufacturing, sampling plans and other statistical modelling
This organisation highly regards thinkers who are empowered to generate and deliver solutions for customers, community and environment. They deliver reliable, durable, high performing services to their partners and opportunities await the right person in this position.
If you are driven, determined and want to step up in your career, this is the role for you. Great career progression opportunities await the right person in this exciting Senior QA Manager job.
If you would like to apply for this role or find out more, please contact LIM Lee Ling on +60 4-240 2132 or email to email@example.com quoting the Job Reference No. 1833430.
Do note that we will only be in touch if your application is shortlisted.
Agensi Pekerjaan Robert Walters Sdn Bhd
(formerly known as Robert Walters Sdn Bhd)
Business Registration Number : 729828-T
Licence Number : JTKSM 423C
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