QRC Assistant - Pretoria Verfied

R 10K-15K per month Pretoria, Gauteng Pretoria, Gauteng more than 14 days ago 25-06-2019 10:05:33 AM
20-08-2019 10:05:33 AM
Quality, Regulatory & Compliance Assistant (Intern - Medical Devices)
Pretoria North
Job Type: Full Time
Salary: R10 000 to R15 000 p/month + Standard Benefits

If not, please don’t apply as your application will be discarded without review!

? Aged: 28 - 40
? Demonstrated knowledge of relevant ISO 9001 or 13485 Quality Management Systems
? Demonstrated knowledge of SOP-124 Sales
? Demonstrated expertise in MS Windows & MS Office
? 2 years’ experience QMS Administration (min. req.)
? Knowledge of typing out of policies
? Extensive experience of working in a quality environment
? Regulatory Affairs implementation in the Medical Device (or related industries)
? Knowledge of legislation and relevant Codes of Practice.
? South African citizen
? Valid Driver’s license

Position Description:
The purpose of this position is to provide support to the overall functions on QRC aspects. The QRC Assistant will assist in the implementation of Quality Assurance, Regulatory Affairs and Post Market Vigilance for our client.
This role works in collaboration with the local SSU Team to define and implement QA strategies, promote quality in service delivery, continuous improvement, monitoring compliance, identifying and evaluating deficiencies, and minimizing business risk while operating within the ISO 9001 and 13485 Quality Management Systems and SOP-124 Sales and Service Unit QMS.
The incumbent will support the QRC Manager in ensuring products supplied in Africa meet and are in compliance with the requirements of regulatory bodies and local law.

Functions:
Product Registration with local Regulatory Bodies and any local authorities as required by local and international law.
Assist in obtaining ISO 13485 certification for local Quality System as required by South African Health legislation.

Key duties and responsibilities:
• Quality Assurance
• Support in implementation, maintenance and certification of ISO 13485:2016 at all sites.
• Assist in integration of Sales and Service Unit QMS and ensure on-going compliance.
• Assist in efficiently managing non-conformances and CAPA within the business.
• Maintenance of document & data control.
• Maintenance of internal audit schedules as well as participate in audits conduct by Group or Regional QRC dept.
• Assist with internal quality audit

Assist the QRC Manager with Regulatory Compliance for the African SSU

Assist the QRC Manager with Post Market Activities:
• TrackWise
• Ensure warranties, unplanned service, product incidents, BNPC, Non-conformances and CAPA are reported into Trackwise as instructed or
required by Local or Global SOP
• Ensure input meets expectations,

In conjunction with the QRC Manager, assist with the following:
• Be an agent for good QRC practices.
• Build team’s knowledge of QRC requirements.
• Induct new employees on QRC requirements.
• To identify, lead and direct process improvement of QRC activities.

Risk Management
• Assist with ensuring that business continuity plan is implemented and audited,
• Assist with audit site processes and procedures for compliance,
• Audit external suppliers for compliance to QMS practices

General
• Keep informed regarding pending industry changes, trends, and best practices and assess the potential impact of these changes on
organizational processes.
• Assist with design and implementation of improvements in communication, monitoring, or enforcement of compliance standards.
• Keep QRC Manager informed of all quality, regulatory and vigilance issues that will have an effect on the business.
• Ensure that Quarantine “Store” is neat and that faulty devices are accounted for.
• Any projects or tasks as specified or requested by the QRC Manager, Senior Director, Quality & Regulatory Compliance, Sales and Service
– RoW.

Qualification (Knowledge, Skills and Abilities):
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:

Knowledge/Skills/Experience:
Each organization shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed and shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
• Demonstrated knowledge of relevant International standards particularly ISO 13485 or ISO 9001 Essential.
• Knowledge of current risk management standards, principles and frameworks.
• Desirable :
• QMS and/or Regulatory Affairs implementation in the Medical Device or related industry
• Knowledge of legislation and the ability to acquire knowledge of the relevant Codes of Practice.

Education or qualifications:
• 2 years’ experience in QMS administration role.
• Previous background and work experience:
• Experience with handling customer complaints,
• Participated in creation and implementation of a certified QMS (ISO 13485/9001),
• Experience with ISO13485 will be a distinct advantage for this role,
• Experience in monitoring, reviewing and completing activities according to previously defined priorities,
• Demonstrated expertise with Microsoft Windows operating system and MS Office applications.

Personal qualities:
• Takes initiative, positive attitude and willingness to assist,
• Practical & logical understanding,
• Team player and work independently,
• Excellent interpersonal and communication skills,
• Strong impact and presence. Ability to motivate and influence people.
• Strong organizational skills.
• Ability to manage several projects.
• Confident in engaging and working with Senior Management, project manager and contractors
• A full assessment will be part of the search and hiring process.

***Note to all serious applicants***

Please forward me your updated detailed resume (in MS Word format if possible) with as many supporting documents as possible:

• Secondary Education (Matric / Gr. 12)
• Tertiary Education
• Other Qualifications & Achievements
• Copy of ID
• Valid Driver’s license
• Latest salary advice
• Reference letters / Letters of Endorsement
• Recent photo (Head & Shoulders)
• Detailed cover letter (work experience, skills, etc.)

Also included in your resume must be the following:
• Current Salary & Benefits versus Expected Salary & Benefits (Total Cost to Company) - Detailed
• Availability (Notice period)
• Relocation: Yes / No
• Full contact details

*PLEASE ENSURE THAT ALL INFORMATION SUPPLIED IS FACTUAL AND CORRECT

If you have not had any response in two weeks, please consider your application unsuccessful. Your profile will be kept on our database and we will connect with you with any other suitable roles or positions

We are eagerly anticipating your reply.