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Senior QA Specialist

1 month ago

Jakarta, Indonesia Boston Scientific Corporation Full time

**Work mode**:Hybrid

**Onsite Location(s)**:Jakarta, ID

**Job Summary**

Provide Quality expertise to support the country business objectives as well as provide guidance to employees to facilitate continuous quality improvement and ensuring compliance with Quality System activities (programs, policies, processes, procedures) to achieve stated objectives. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned functional, site, and corporate quality goals and priorities. 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.

**Key Responsibilities**
- Act as team member in supporting quality disciplines, decisions, and practices.
- Implementing, maintaining and improving the quality system at the sites.
- Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
- Is responsible for continuous Quality System efficiency and effectiveness and promoting solution-driven behavior.
- Monitors, identifies and reports on key Quality System indicators and takes appropriate action to address areas for improvement.
- Advise management on potential improvements or enhancement to quality systems and processes in the company.
- Understands, interprets, and applies Documentation Control principles and processes to ensure compliance with Corporate, ISO, GDPMD regulations and standards with unyielding integrity.
- Promotes and develops quality awareness in every employee, while helping the site organization towards improved quality performance and ownership as well as customer and regulatory/compliance oriented initiatives.
- Maintains, advises and reports on compliance to Corporate Quality System, International on Local Requirements and Regulations as well as Quality Policies and Procedures to site Management Team and other employees on how to achieve compliance for the aforementioned Quality System elements, as applicable to the site.
- Frequently interacts with and represents the quality function to certain BSC departments like Operations, Regulatory, Sales and others, as key Quality System processes are managed by those areas (e.g. Complaint reporting, Field Action execution, etc) - May also interact with national regulatory authorities.
- 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.

**Job Requirements**
- Bachelor’s Degree in Pharma/science/technical/health related field (e.g., Biology, Nursing, Biomedical sciences).
- At least 5 years’ working experience in Medical device related Quality Assurance.
- Good knowledge in ISO13485 and GDPMD
- Fluency in English required; other language skills are a plus
- A good team player, with strong inter-personal skills
- Manages work in a confidential manner, ensuring information is shared with internal and external individuals in an appropriate manner; provides guidance to peers as necessary regarding proprietary information
- Able to demonstrate good judgment and is self-motivated
- Excellent communication skills, both verbal and written

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