Quality Assurance Manager

Key responsibilities and activities:

General Quality Assurance

Responsible for generating, implementing and monitoring cross-functional quality processes, throughout life cycle of company and products

Review, edit and maintain all pre-established QMS policies including training, CAPAs, ECOs and MRBs.

Implementation, upgrade and broadening of the company’s SOPs

Manage company’s training procedures

Manage company’s daily QA activities

Prepare and manage audits and certification tasks

Manage QA goals to align with company’s long term strategy and regulatory requirements

Manufacturing & Operation a. Monitor design transfer to production

b. Manage and perform incoming inspection and approval processes

c. Manage company’s equipment maintenance

d. Implement inventory management procedures

e. Responsible for product release procedures

f. Contractor/Vendor management

Define QC/IPC procedures

Compilation of DMR and DHR

Design Control, Verification and Validation a. Compilation of DHF and Technical Files

b. Participate in the definition and execution of V&V testing protocols and associated rationales

c. Lead validation activities related to product release procedures (e.g. sterilization, packaging, transportation)

d. Proactively involve with Eng/RD with the ability to support to D&D activities

e. Maintaining risk management file and cross functional related activities

Requirements:

B.Sc. degree or higher in a technical discipline, preferably in a life science related field

3+ years' experience in implementing or managing quality systems in medical devices, class III preferred.

Experience working under ISO13485

Critical thinker, proactive approach, highly motivated and accountable

English language proficiency (speaking, writing document)