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Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

This position is for a Sr. Manufacturing Quality Engineer l with hands-on experience and proven success in managing Quality systems.   The successful candidate will be responsible for partnering with sterilization and microbiology Subject Matter Experts to assist in root cause investigations related to sterility and microbiological outputs, review and assess the accuracy and sustainability of process requirements as they pertain to sterility assurance and microbiology and drive cross-functional collaboration with quality groups across the organization.

This role requires a strong quality mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance.

The ideal candidate should demonstrate proficient experience with quality management concepts including but not limited to eQMS, risk assessment, PFMEAs, process controls, root cause investigations, CAPA, and continuous improvement  

SUPERVISION RECEIVED

Under direct supervision of Sr. Quality Compliance Manager, Environmental Controls.

SUPERVISION EXERCISED

Indirect supervision of CMP QMS Workstream Team Members.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

Process Oversight:

• Assist in root cause investigations related to integration of sterility and microbiological requirements during process and product risk management.
• Review, assess, and update process and risk mitigation requirements as they pertain to sterility assurance and microbiological endpoints.
• Collaborate in the development of a risk-based approach to defining sterility-related and microbiological requirements.

• Drive integration of product sterility considerations into process risk files.

• Ensure compliance with industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements.

Cross-Functional Collaboration:

• Work closely with sterility assurance and microbiology teams to ensure sterilization and microbiological processes are integrated into the overall process risk management process.

Regulatory Compliance & Documentation:

• Ensure thorough documentation and records related to sterility assurance and microbiological endpoints as they pertain to process and risk management files.

• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor’s degree in science, Engineering (Biomedical or Mechanical) or related 
  discipline, with 5+ years of experience in Quality Assurance role for medical 
  device or pharmaceutical manufacturing, or equivalent education and years of experience. Or, master’s degree in science, Engineering (Biomedical or 
  Mechanical) or related discipline, with 0-2 years of experience, or equivalent 
  education and years of experience. 
• Demonstrated knowledge and understanding of applicable national and 
  international regulations and standards for Design Controls.
• Demonstrates excellent organizational, verbal and written communication skills. 
• Proficient with the MS Office Suite, and statistical software. 
• Must be able to work independently with minimal supervision. 
• Able to prioritize projects and manage time to meet organizational goals and 
  objectives. 
• Experience with External Regulatory Agency audits (i.e., Notified Bodies and 
  FDA). 
• This position could require up to 25% travel.

Preferred Skills:

• Experience using eQMS software solutions. 

• Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards. 

• Experience using analytical tools to drive data-based decision making.