Quality​/Compliance Analyst

Quality/Compliance Analyst

DePuy Synthes is recruiting for a Quality/Compliance Analyst located in New Brunswick, NJ or in Raynham, MA or West Chester, PA.

This role is responsible for executing and supporting regional operations in the areas of Document Management, Quality, Compliance, and SOX Reporting and for providing superior advisory and analytical support to internal and external customers enabling the compliant execution of critical customer focused operations.

Key Responsibilities:

• Support and continually work within the parameters established by a risk-based Quality Management System framework.
• Serve as the Customer Service (CS) Subject Matter Expert (SME) regarding SOX financial reporting, Quality and Compliance.
• Benchmark internally and externally, regionally and globally, to gather, share, and implement standard methodologies accordingly.
• Assist CS Senior Leaders with development and implementation of organizational and strategic plans designed to improve efficiency of department processes, using technology and other platforms to standardize, leverage and/or eliminate manual interactions wherever possible.
• Lead and manage projects related to broader Supply Chain initiatives, as required.
• Your Key Performance Indicators for this role include on-time completion/compliance with SOX reporting.
• Support change management strategies by applying change management principles and tools
• Support the development and maintenance of internal resources to provide accurate SOX financial, Quality and Compliance information.

Day-to-Day

Activities:

10%

• Provide CS Quality & Compliance expertise on applicable projects.
• Lead and/or support key departmental/cross-functional/cross-sector projects, as assigned, by developing and utilizing in-depth knowledge of business processes and systems, as well as project management skills.
• Use continuous improvement tools and methodology, including Process Excellence, LEAN, and project management, to identify, evaluate, challenge, develop solutions, and optimize business processes that drive measurable improvement.
• Regularly communicate in all directions to keep associates, peers, and Management informed of project status, process changes, and opportunities.
• Drives / supports regional and global CS projects for the US region using FPX methodology, tools and best practices. Conducts lessons learned post-implementation and identifies opportunities to continuously improve.

Day-to-Day

Activities:

10%

• Support documentation management, Quality, and Job Function Curriculum (JFC).
• Support with managing departmental/Regional Change Control documentation and deliverables to ensure the on-time completion.
• Support with the on-time completion of Annual Training Record Review (ATRR) and lead on-time completion of controlled document periodic review.
• Support with Key Performance Indicators for On-Time Periodic Review.
• Support with development, implementation, and evaluation of metrics with meaningful insights for customer service in the areas of Document Management.

Day-to-Day

Activities:

10%

• Complete required compliance/assigned training by required due date.
• All duties as assigned by manager and/or supervisor.

Qualifications

Education

• Required:
  
  Bachelor's degree in Quality, Engineering, Supply Chain, Life Sciences, Business, or a related field.
• Preferred:
  Coursework or concentration in Quality Management, Regulatory Affairs, or Operations.

Experience and Skills

Required:

• 2 to 4 years work experience in relevant Quality, Compliance, or Supply Chain position within a regulated, fast-paced business environment required
• Work experience in Quality, Compliance, Document Management/Control, Technical Writing, or Supply Chain
• Ability to analyze basic data and identify trends to support continuous improvement.
• Proficiency with standard office and data tools (e. g., Microsoft Office).
• Demonstrated time management skills with consistent track record to handle multiple competing priorities/deadlines, ability to act with a sense of urgency, and deliver expected/exceeding results

Preferred:

• Experience in a medical device, pharmaceutical, or other regulated industry.
• Exposure to audits, CAPA, change management, or supplier quality…