Quality Specialist, South Africa
Job details
Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the Role Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities. Collaborates with Quality Management to design and implement functional process improvements. Assists in development and maintenance of quality methodologies, systems and practices which meet Boston Scientific (BSC), customer and regulatory requirements. This position is located at the Johannesburg office, and offers weekly hybrid working (two days remote, three days in the office per week). Your responsibilities:
- Assists in the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
- Supports departmental, functional, divisional, and corporate quality goals and priorities.
- Acts as team member in supporting quality disciplines, decisions, and practices.
- Builds quality into all aspects of work by maintaining compliance to all quality requirements.
- Execute CAPAs and participate in improvement projects as appropriate.
- Execution of field actions and handling product complaints, document review and Supplier management.
- Managing processes at a Third-Party Logistic (3PL) warehouse.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- A degree qualification in scientific subjects, such as Biological Sciences or Health Sciences.
- Proven experience within Quality Assurance, either from the medical device industry, or from the pharmaceutical sector.
- Experience of CAPA, managing non-conformances.
- Experience in executing field actions, handling product complaints and documentation reviews.
- Good understanding of governing regulations and experience in managing processes at a Third-Party Logistic (3PL) warehouse.
- ISO13485 lead auditor experience is beneficial.
- Proactive and innovative team member with problem solving expertise.
- Highly organised with excellent attention to detail.
- Internal and external communication skills.
- English language skills, both written and verbal, at a professional working proficiency level.
- Experience in a ground-breaking multinational company with attractive benefits.
- Upskilling.
- Mentoring.
- A company with a purposeful mission.
- Hybrid working.
- Permanent position.
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