Arrotek Medical is a medical device engineering company offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market. We strive to provide employees the opportunity to work in a competitive, growing and dynamic environment, for career development and employee wellness through providing a competitive employee package.
The responsibilities for this position will include the following:
- Assist with the development and maintenance of quality evaluation and control plans and protocols for processing materials into finished products.
- Assist with the confirmation that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements.
- Issue of Product paperwork/batch records to manufacture and also review and release of same and compile COA/COC
- Approval of change requests for product, process and quality changes.
- Generation and management of process deviations, non-conformances, supplier complaints, reworks, CAPA, complaints, rejects and change notices.
- Preparing and updating Operations procedures and associated documentation.
- Quality review of responsible area validation documentation.
- Performing an active role in further development and continuous improvement of the QMS.
- Liaise with suppliers and customers on quality related issues.
- Assist Head of Quality in implementing and maintaining the QMS.
- Conduct internal audits, including closing out audits in a timely manner, creating audits finding reports and determine proper corrective and preventive actions.
- Create, maintain and issue company quality documentation, such as SOP’s, and WI’s.
- Support customer and surveillance accredited audits.
- Drive continuous improvement and best practices in QMS “Right First Time”.
- Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations.
- Updates job knowledge by participating in educational opportunities.
- Ensure compliance to all applicable regulatory standards and cGMP procedures and practices.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position by their manager.
Candidates likely to be called for interview will have most or all of the following:
Qualifications and Education
- Minimum Degree in a Science or Engineering discipline.
- 3-5 Years’ experience working in a medical device environment in a Quality role.
- Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
- Internal/external auditing experience would be an advantage.
- Validation experience including Sterilization, process and packaging validations would be beneficial.
- Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.
- Understand general principles of ISO 14971.
- Decision making ability coupled with the ability to work on own initiative and with minimum supervision is required, and
ability to multitask and prioritise.
- Demonstrate detailed working knowledge of the medical device industry.
- Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, suppliers and customers.
- Desire to learn new tasks and flexibility.
- Attention to detail while maintaining awareness of longer-term objectives.
- Capacity to maintain the highest level of confidentiality internally and externally.
- Have MS Office Experience (Word, Excel, PowerPoint etc.)
- High level of teamwork and engagement, while at the same time being able to work on their own initiative/ Excellent communication skills, both written and verbal,
maintaining confidentiality at all times/ Excellent attention to detail, with strong numerical and problem-solving ability
- Permanent Contract
- Successful candidate will be expected to start ASAP;
- Full time position.
Interested applicants should submit their up to date CV and Cover Letter to firstname.lastname@example.org. All applications will be treated in strict confidence.
Arrotek Medical is an equal opportunities employer.