Quality Assurance Manager

Benefits:

• 401(k) matching
• Competitive salary
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

CURIS System is a growing Bio-decontamination company specializing in integrated systems for the Life Sciences, BioPharma and Healthcare facilities and installing bio-decontamination equipment nationwide. Our team is growing due to the principles of quality service, integrity, transparency, and hard work focused on superior customer satisfaction. We are looking for a Project Lead who is willing and able to manage while working with a small design and implementation teams. Candidates are expected to have a construction background and familiarity with electrical work, building regulations, structural steelwork, and reading blueprints/schematics.

CURIS is looking for a Quality Manager who has expertise in mechanical / electrical/ pneumatic fields. This candidate must be a hardworking individual talented at investigating new applications and working in cross-functional teams. They must be enthusiastic and eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Motivated to learn, grow, and excel in any industry. This position would be responsible for the following rolls and responsibilities….

• Verify production and special projects compliance with quote/POs, internal submittal, and design drawings
• Assist in development of quality goals for newly initiated R&D projects to inform the design process towards zero-defect product release
• Understand pneumatic systems assembly/diagnostics and network/hard wired logic control systems
• Containment systems design & testing, operator exposure testing, pressure decay and leak testing
• Assist sales team with technical backup at their presentations, pre/post sale.
• Liaison between engineering and production departments, facilitating communications and maintaining appropriate awareness on project developments to facilitate quality processes and forecasting
• Develop, configure, and optimize quality processes from inception to start up and validation or certification in accordance with industry standards
• Prepare and present technical information to team members and management
• Maintain a working knowledge of government and industry quality codes and standards
• Verify compliance with detailed process documentation and operational instruction for work being conducted in the manufacturing areas and on-site using SOPs. Assist and advise on the creation or updating of non-existent or outdated policies.
• Prepare, check, and coordinate documentation to corroborate equipment design and application to include (but not limited to) commissioning items, FAT, SAT, IQ/OQ/PQ, calibration and maintenance deliverables, user manuals, and troubleshooting guides
• Use Microsoft Word and other software tools to create documents and other communications.
• Demonstrate respect, friendliness, and willingness to help wherever needed.
• Support customer service efforts by communicating with customers as needed in a friendly, efficient manner following outlined steps of service
• Aseptic process cycle development
• Calibration, airflow system validation, 3rd party equipment integration
• Evaluate existing procedures and make proactive adjustments to meet changing demands
• Use critical thinking to break down problems, evaluate solutions and make decisions which mutually support quality and business objectives
• Support and mentor project/electrical/mechanical design teams & production/site teams by providing a quality perspective for incorporation early in the design process
• Involve all team members to ensure quality is seen as individually driven & maintained in a team environment
• Actively track equipment troubleshooting requests to capture relevant quality KPIs based on issues experienced in field or via RMA
• Create standard validation protocols for decontamination services and organic laboratory services
• Commission /Validate/Service Pharmaceutical Aseptic and containment equipment

Ideal background would include…
Electrical engineering management, commissioning engineer, project manager with 5 years' experience. Committed to providing unprecedented technical support to clients. May have recent experience in Pharma commissioning & consultancy.

Additional Skills may include…

• Calibration of Pressure transmitters, Magnehelic gauges, Airflow sensors, Flow meters
• Airflow balancing within facilities and standalone downflow booth systems with airlocks
• Proficient with measurement, calibration, and test equipment
• Detail oriented, good organizational traits
• Knowledge of general safety and hygiene practices
• Strong analytical, problem-solving skills
• Strong written and verbal communication skills
• Ability to work in a team-oriented environment
• Quality Assurance
• Experience in a clean room environment and aseptic manufacturing environment
• Mechanically inclined with troubleshooting aptitude
• • Knowledge of manufacturing methods, process & quality standards (ISO 9001, 21CFR Pt11 Electronic records & Signatures)
• Electrical/Mechanical Blueprint Reading
• P&ID reading for verification
• Process Flow Diagrams
• HEPA Filter Testing
• Particle Counting
• Pressure Decay/Leak Testing
• DC & Variable Speed Drive Systems
• Electrical System Diagnosis
• Commissioning/Validation of Containment/Aseptic Systems
• Customer Service & Aftersales Support
• Document Writer for policies and cause and effect documentation
• Compliance Within cGMP Environment
• Microsoft Excel/Word/Project/Powerpoint
• Compliance With NEC Electrical Codes/ATEX/UL
• Electrical Panel Building knowledge – basic for verification