Quality Assurance Manager

QA Manager for Medical Device start-up with Class3 product

Key responsibilities and activities:

General Quality Assurance

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

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

c. Implementation, upgrade and broadening of the company’s SOPs

d. Manage company’s training procedures

e. Manage company’s daily QA activities

f. Prepare and manage audits and certification tasks

g. 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

g. Define QC/IPC procedures

h. 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)