Principal Quality Systems

4 weeks ago

Riyadh, Saudi Arabia Boston Scientific Corporation Full time

**Principal Quality Systems & Compliance Specialist**:

- Work mode: Hybrid- Onsite Location(s): Riyadh, SA**Additional Locations**: Saudi Arabia-Riyadh

**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.

**Purpose**
- Providing technical expertise to Quality and supporting functions within the site/region.
- Responsible for implementing continuous improvements and provide vision and leadership for strategic projects and maintaining the Quality System, including Quality Assurance mandates. Identifies and assures optimal product and process quality within quality system and regulatory requirements. Understands and applies quality principles to support an effective overall quality system, including initiatives in conjunction with the Director Quality Assurance.
- 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.

**Responsibilities**
- Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, regional, divisional and global quality goals and priorities.
- Takes a lead role in the coordination and execution of acquisition & distributor management activities within the region.
- Exercises a high degree of technical autonomy through developing and managing an efficient and effective Quality Management System which complies with all current medical devices standards and regulations.
- Is viewed as a leader in the areas of QSR, cGMP and ISO/MDD standards within the Quality organization, making appropriate decisions on a daily basis using the Quality Manager/QA Director as the final arbitrator on critical quality decisions.
- Is responsible for implementation, oversight, and maintenance of ISO 13485 country certification.
- Establishes the industry benchmark for Quality Systems best practice, determines robust, practical, compliant solutions for the business.
- Leads system improvement teams selecting appropriate techniques for problem solving and process improvements.
- Champions continuous improvement & innovation within the QA Dept. & Region.
- Takes a lead role in the management and execution of the Regional Management Review.
- Participates in the internal audit program & plays a lead role in the preparation and execution of audits by external parties.
- Collaborates and liaises with the Global Quality Systems team and relevant working groups to drive continuous improvement.

**Requirements**:

- University Degree as a minimum.
- 8 years’ + experience in the Medial Device, Pharma or Manufacturing industries
- Has extensive External Audit and Quality Systems experience.
- An excellent communicator with the ability to influence others.
- Strong command of the English & Arabic language (verbal & written)
- Demonstrates a high level of initiative & autonomy through continuous questioning of current practices.
- Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department objectives.
- Project Management /Green Belt certification preferred.

**Requisition ID**:573659

**Job Segment**:QA, Quality Assurance, Law, Medical Device, Technology, Quality, Legal, Healthcare

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