You will be the main person in charge of leading the company's quality and regulatory compliance efforts, ensuring premium product quality and customer satisfaction.
You will also manage the budget and achieve corporate QARA targets.
This company is a leading provider of innovative medical technology solutions in Malaysia.
With expansion plans underway, this is a great time to join the award-winning team.
Description
Manage various QC programs/processes within the department (training, sample management, data review and reporting) and serve as subject matter expert (SME).
Coordinate and facilitate QC activities to meet commitments on-time.
Ensure QC personnel have appropriate training.
Lead planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification.
Assist in troubleshooting of test methods and/or equipment as required.
Author, review, and/or approve data, SOPs, COAs, and DHRs.
Monitor, track and publish QC metrics.
Ensure all QC records and DHR documentation adhere to cGMP/GDP expectations.
Lead compliance-related teams working towards the goal of continuous improvement.
May be required to lead NCMR, OOT investigations/deviations and to identify corrective actions to prevent reoccurrence.
Serve as QC representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all QC needs.
Participate in internal and external quality audits.
Profile
Education: Diploma, Degree, or Master's in a related field, preferably in Sciences.
At least 5 years or more in Medical Device Quality Operations with a minimum of 2 years at managerial level.
Fluent in both English and Malay.
Ability to communicate and work effectively at multiple levels within the organization.
Must possess strong leadership and analytical skills with a team-focused attitude.
Experience in leading or supporting ISO 13485, MDSAP or FDA audits/inspections.
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
Intermediate to advanced skill level of MS Word, Excel, Access, Auto Cad or equivalent.
Job Offer
13th month.
To apply online please click the 'Apply' button below.
For a confidential discussion about this role please contact Joanna Darmarajah at +60323024048.#J-18808-Ljbffr