Quality Officer

2 weeks ago

Gelang Patah, Malaysia Owen Mumford Sdn Bhd Full time

**Key Responsibilities**:

- Manage and develop labelling for new and existing products in line with customers' needs and regulatory requirement.
- Create and update labelling using label management software as per specification on time to support smooth production.
- Work with quality compliance assistant to ensure the first sample verification for label is carried out effectively.
- Understand and manage labelling database and label management software and work on improvements required to have a more efficient label management system.
- Review proposed marketing materials, packaging, Instructions For Use and Label for Regulatory compliance to MDA and to the appropriate requirement for ROW markets.
- Support the product team and project team to provide essential support for product development projects.
- Prepare and collate required documentation to support submissions for product approval and license maintenance (e.g. Variations to Marketing Authorisations etc)
- To support and work with distributors in APAC region to ensure OM product meets new or update regulatory requirements in different market.
- Maintain effective and efficient administration of Change Control for Owen Mumford Sdn. Bhd.
- Create and update relevant QMS procedure and working instructions.
- Undertake additional duties as requested by line manager or department manager.
- Complying with Owen Mumford policies and procedure and fulfil roles and responsibilities as defined to support full compliance.
- Identifying areas or improvement in daily work.
- Completing work to agreed priorities and meet due dates. Report to those in authority if any timelines are likely to be missed.
- Listening to performance feedback provided and takes any necessary improvement action.
- Completing personal Training and Development Plan and seek opportunities to grow and learn.

**Requirements**:

- Bachelor's degree, diploma or equivalent from accredited college or university.
- None or 2 years equivalent working experience in a manufacturing.
- Basic understanding of ISO 13485 or ISO 9001.

**Job Types**: Full-time, Permanent

**Salary**: From RM1.00 per month

**Benefits**:

- Free parking
- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development

Schedule:

- Monday to Friday

Supplemental pay types:

- Performance bonus

**Education**:

- Diploma/Advanced Diploma (preferred)

**Experience**:

- Quality control: 2 years (preferred)

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