QA Manager

5 days ago

Klang, Malaysia SteriPack Asia Sdn Bhd Full time

We are hiring a highly dedicated **QA/RA Manager** who will **manage all quality matters** in the company and act as the **Management Representative** as defined in the ISO 13485, 21 CFR Part 820 (FDA cGMP), Regulation (EU) 2017/745 or any other relevant standards and regulations.

**What do you need to have to be successful in this role?**
- At least **three (3) years’ experience at the Managerial level in handing medical devices Quality Assurance/Quality Control tasks.**:

- Preferably with at least one year’s experience working in a manufacturing environment that is ISO 13485 certified.
- **Knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP.**:

- Have similar experience working in cleanroom environment.
- Able to work in a team and under minimum supervision.
- Strong interpersonal, analytical and problem-solving skills.
- Proactive, resourceful, willing to learn.
- Good written and spoken English and Bahasa Melayu.
- Computer literate.

**What will your role be?**
- ** General**:

- Ensure that the compliance with ISO 13485 and other applicable regulatory requirements or quality-related standards.
- Ensure that SOP’s and Work Instructions relating to the department are followed and are updated when needed.
- Ensure that the Quality Department is always adequately staffed and trained including internal auditors.
- Ensure that the company’s Quality Management System is established, implemented and adequately maintained; its efficiency is continuously improved, and that the system always complies with the requirements of the relevant regulatory agencies.
- Ensure the promotion of awareness of regulatory requirements and customer requirements throughout the organization.
- **Quality System**:

- Ensure that all procedures and work instructions that could affect quality are described in the Quality Management System.
- Ensure that all procedures and work instructions described in the Quality System are following ISO 13485, GMP, product ISO standards and other applicable regulatory requirements at all times and ensure relevant parts of the Quality System are updated accordingly.
- **Audit**:

- Ensure that internal audits are performed on a regular basis and that all areas in the Quality System are audited.
- Assist in supplier audits and approval of new suppliers.
- **Non-Conformances**:

- Ensure that Customer Complaints are correctly handled and responded to.
- Ensure that all Non-Conformances are reported and attended to correctly and within reasonable time limits.
- Ensure that corrective actions are taken in such a way that the Non-Conformances are solved and do not re-occur.
- Authorize to stop production & stop the delivery of goods to customer whenever there are any non-conforming products observed.
- **Inspection**:

- Ensure that there is adequate inspection performed and all goods to be inspected have proper inspection criteria.
- Ensure that goods rejected at inspection, or lacking inspection criteria, are not transferred to the next stage.
- Ensure that NC is issued for every non-conformity observed during inspection.
- **Engineering Change Order/ New Products**:

- Ensure that new/revised products cannot be sold until all necessary steps, including updating of MFG/PRO, validation, device registrations, etc, have been performed and correctly documented.
- **Release of Products**:

- Ensure that Certificate of Conformance is created for all sold products.
- Ensure that sterilized products and finished goods from sub-contractors with COC are released accordingly.
- Ensure that Pharmaceutical Unit’s Batch Records are released accordingly.
- Authorized to release the finished Pharmaceutical products to customers.
- **Management Review**:

- Ensure that Management Review is performed regularly and in accordance with applicable processes.
- Ensure that the Management Review agenda is established and information needed for the Management Review is available during the Management Review.
- **Validation**:

- ** **Ensure that validation, annual validation review and product stability study are carried out accordingly.

Are you ready to make that career shift? Trust us, this role is always on-demand and you will grow a great portfolio with us. Click that ‘**APPLY TO THIS POSITION**’ button and we will talk to you soon.

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