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Principal Quality Specialist

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

New Delhi, HR, IN

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.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • 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.

Quality System Requirements

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.

For those individuals that supervise others, the following statements are applicable:

 

  • 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.

Management Requirements

 

  • Indirect and direct Managemnet skills are must.
  • Provide strategic leadership support to QA specialists in India commercial team and must be able to influence other functions while leading CFT projects.

Job Scope and Leveling Guidelines

 

Knowledge

A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

 

Problem Solving

Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.

 

Planning and Organization

Plans, organizes, and prioritizes own daily work routine to meet established schedule.

 

Discretion/Latitude; Supervision Received; Decision Making

Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established policies, procedures and practices.  Work is reviewed for soundness of judgment.

 

Business Relationships and Project Management

Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.

 

Impact

Contributes to the completion of departmental projects and goals. Errors in judgment, poor recommendations, or failure to achieve results would normally require a moderate expenditure of resources to rectify.

 

Liaison

Engages with internal company and external contacts. Represents organization on specific projects.  Uses diplomacy and tact in interactions and problem solving.

 

Mentoring

Provides guidance to less experienced staff.

 

Requirements

Qualifications & Experience:

  • Bachelor’s Degree in science/technical/Engineering/ health related field (e.g., Biology, Nursing, Biomedical sciences).
  • At least 12-18 years’ working experience in medical device(preferred) related Quality Assurance.
  • Good knowledge in ISO13485 and India MDR
  • 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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Job Segment: Compliance, QA, Quality Assurance, Law, Biomedical Engineering, Legal, Technology, Quality, Engineering

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