Compliance Engineer II

Responsibilities

• Support Process Engineering Lab Quality Directives gap analysis and closure plan execution.
• Perform risk assessments, investigations, documentation and procedure updates, qualification writing and execution.
• Drive effort to manage DPE’s SOPs to ensure GMP, FDA, and ISO compliance.
• Support Compliance and Documentation Systems for DPE (Global Document Management System for protocols/reports and procedures; CATSWeb for non-conformances and CAPAs; Compliance Wire Learning Management System for training; Kintana for change control, conduct risk assessments as they pertain to Quality System compliance).
• Support systems for PMs, Calibration, Environmental Monitoring, and storage of clinical trial materials and products.
• Manage and maintain the Master Validation plan for the qualification and requalification of equipment, facilities and software.

Requirements

• Bachelor’s Degree in Science/Engineering strongly preferred and/or certification as a Quality Engineer.
• 3+ years’ experience with medical devices and/or clean room environment compliance regulations with Quality Engineering experience strongly desired.
• Specialized Training: ISO-9000, GMP, medical device manufacturing experience, technical writing, equipment and software qualification documentation, Lean/Six sigma.
• Special Skills: Computer competent with Microsoft Office suite; ability to learn specific software systems utilized in B&L's growing Quality Systems (Documentum, Kintana, CATSWeb).
• Ability to develop working relationships with various internal core competencies and work as a team member.
• Active participation in Process and Design FMEA activities
• Strong Communication, Organization, Report Writing skills

Pay

Starting pay for this role is between $65,000.00 and $100,000.00. The actual base salary offered may depend on a variety of factors.

Schedule

N/A