Compliance Engineer II

Bausch + Lomb • US-NY-Rochester, NY

3d • Onsite

About The Position

The Compliance Engineer II will provide technical support of Departmental Technical Documentation activities and the development, implementation and effectiveness of Development Process Engineering's (DPE's) procedures and systems for compliance to the quality directives. This includes but is not limited to gap assessments of directives and DPE's processes and procedures, training, procedure effectiveness, metrics for tracking performance, qualification and validation support of equipment, facilities and software, conducting risk assessments, technical writing and electronic filing and storage of information, support internal audits and corrective actions.

Requirements

• Bachelors 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
• 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
• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

• Regulated Medical Device or Pharma industry
• Use and knowledge of Lean and DFSS tools and software

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.

Benefits

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review
• company holidays
• well-being benefits
• sick time
• floating holidays
• paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level