Quality Specialist, Romania Job Details

Job Description

Quality Specialist, Romania

Work mode: Hybrid
Onsite Location(s): Bucharest, RO
Additional Locations: N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, well give you the opportunity to harness all thats 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, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

Senior Quality Specialist Romania (2-Year Contract)

The Senior Quality Specialist will serve as the primary Quality liaison for the Boston Scientific Romanian Affiliate and all Southeast Europe (SEE) distributors, fostering enhanced awareness, visibility, and communication regarding quality initiatives. This role supports departmental, functional, site-level, divisional, and corporate quality objectives and priorities. The specialist will collaborate closely with the EMEA/GEM Quality Management team to design and implement process improvements that drive functional excellence. Additionally, the position contributes to the development and maintenance of quality methodologies, systems, and practices that align with Boston Scientific (BSC) standards, customer expectations, and regulatory requirements.

• Location: Bucharest, Romania
• Contract: Temporary (Jan 2026 Feb 2028)
• Work Model: Hybrid (2 days remote, 3 days in-office weekly)
• Reports To: Senior Quality Manager, Growth Emerging Markets Central & North (based in Istanbul, Trkiye)

Your responsibilities:

• Leads the development and execution of streamlined business systems, which effectively identify and resolve quality issues in his/her Romania Affiliate and SEE countries.
• 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, provides trainings to both internal and external customers on quality requirements.
• Executes CAPAs and participate in improvement projects as appropriate.
• Executes field actions and handles E2E product complaints, document review and Supplier Management.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented Boston Scientific 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.
• Hosts annual ISO 13485 and ISO 9001 Audits in the Romanian BSC Affiliate.

What are we looking for in you:

• A minimum of a bachelors degree required (preferably Biological Sciences or Health Sciences).
• Proven experience within Quality Assurance, preferably from the medical device industry, or from the pharmaceutical sector.
• Experience in managing non-conformances/CAPA/internal/external audits/risk management.
• The position may require up to 10 PERCENT travel within Europe.
• Experience in executing field actions, handling product complaints and documentation reviews.
• ISO13485/9001 lead auditor experience is preferred.
• Proactive and innovative team member with problem solving expertise.
• Highly organised person with excellent attention to detail.
• Internal and external communication skills. The position plays a pivotal role within the organization and collaborates with all the departments.
• English and Romanian language skills, both written and verbal, at a professional working proficiency level.

What we can offer to you:

• Experience in a ground-breaking multinational company with attractive benefits.
• E2E quality processes responsibility within the region.
• Opportunities for learning and growth.
• A company with a purposeful mission.
• Hybrid working environment with exposure to international collaboration.

Requisition ID: 615182

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isnt just business, its personal. And if youre a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

Job Segment: Pharmaceutical, Compliance, Medical Device, QA, Risk Management, Science, Legal, Finance, Healthcare, Quality

---