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Senior Quality Specialist Job

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Date: Mar 17, 2019

Location: Voisins le Bretonneux, 75, FR

Company: Boston Scientific

 

Senior, Quality Specialist

Job Purpose

Serve 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 recommend, design and implement functional process improvements.  Develops, establishes and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements.  Provide compliance guidance and support for technical development concepts, regulatory, operational, or systems/services.  May mentor cross-functional stakeholders on implementing Quality processes and procedures as appropriate

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.

Key Responsibilities

  • Implementing, maintaining and improving the Global Quality System.
  • Maintain, control, revise and update the Document Management System in accordance with applicable Quality System Standards.
  • Conducts internal/supplier audits in accordance with company policies and procedures and ISO 9001/13485 requirements
  • Support and prepare for site level internal/external audits and act as Subject Matter Expert (SME) in audits.
  • Provide functional support as an SME as applicable to internal & external functions.
  • Pro-actively investigates, identifies and implements best in class Quality Engineering practices and implements/ manage improvement projects within the organization; (VIP, QMP, Star, Lean, 5S).
  • Demonstrate leadership and seniority in Quality Assurance aspects.
  • Act as team/cross-functional team member/lead in supporting quality disciplines, decisions, and practices both internally & externally.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Lead the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
  • Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes.
  • Executes the testing and training development for future roll-outs of business applications.
  • Understands, interprets, and applies Documentation Control principles and processes to ensure compliance with Global Quality System.
  • Drives awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Boston Scientific.

Competencies

Knowledge

A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field.  Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways.  General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.

 

Problem Solving

Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.

 

Planning and Organization

Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.

 

Discretion/Latitude; Supervision Received; Decision Making

Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions.  Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.

 

Business Relationships and Project Management

Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.

 

Impact

Contributes to the completion of specific programs and projects. 

 

Liaison

Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.

 

Mentoring

Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

Qualifications

5+ years’ experience with Bachelor’s Degree or equivalent.

 

 

quality assurance, quality system, medical devices


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