- Fresenius Medical Center (Waltham, MA)
- … Quality and Compliance, Collaboration, No-Limits Mindset and Results Oriented. **PURPOSE AND SCOPE:** Lead Quality Systems Auditor will act as a ... Quality System (QM) audits required by the corporate quality systems audit program, including planning, preparation,...in accordance with the global QS audit program + Lead and manage internal and corporate audit program for… more
- Elevance Health (Smithfield, RI)
- **DRG Coding Auditor Principal** _Virtual: This role enables associates to work virtually full-time, providing maximum flexibility and autonomy. This approach ... and skill development. Alternate locations may be considered._ The DRG Coding Auditor Principal is responsible for auditing inpatient medical records on claims paid… more
- Danaher Corporation (Waltham, MA)
- …ensure communication through corporate policies and procedures, and engaging training. + Lead Quality complaint investigations and ensure timely closure for ... Control Charts, Statistical Methods and Sampling Plans. + Technical Proficiency: Lead Auditor Certification, experience leading investigations and CAPAs, and… more
- Hologic (Marlborough, MA)
- …5+ years in the medical device manufacturing or related industry. + ISO 13485 Lead Auditor Certification. The individual fulfilling this role must possess the ... engineering principles. + Knowledge of **Production Part Approval Process (PPAP)** and ** Quality Management Systems (QMS).** + Familiarity with statistical tools… more
- Hologic (Marlborough, MA)
- …team and play a pivotal role in ensuring the effectiveness of our global Quality Systems . In this critical leadership position, you will define, implement, and ... MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance in regulated...in Life Sciences, Engineering, Medical, or related field. + Lead Auditor certification and qualifications for relevant… more
- Sanofi Group (Framingham, MA)
- …the pharmaceutical, biotech, medical device, or related industries. + Extensive knowledge of Quality Systems and Data Integrity is required. + Strong command of ... + ** Lead cGMP compliance projects** aligned with the company's Quality Operations strategy and US FDA regulations. + **Drive digital transformation initiatives**… more