Position Title : Quality Engineer
Location: Philadelphia, PA - Red Lion Road
Department: Quality -- Validations
Reporting To: Director of Validation
Responsible For (Staff): no
The Quality Engineer has the primary function of supporting the technical aspects on the onboarding of new clients, products, and processes to the Philadelphia site. The role involves utilizing technical expertise, excellent communication, and project management skills in interacting and collaborating with internal team members, customers, suppliers, and contract service providers. The position will be responsible for driving timeline commitments for new projects. The Quality Engineer will also function as a technical resource in deviations, defect analysis, complaints, establishing sampling plans, assessments, and protocols.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Capable of resolving complex issues through collaboration with internal and external parties Participate in External Audits of Suppliers/Contract Service Providers Manage activities and timelines associated with supporting onboarding new business Excellent technical writing skills Development and/or review of technical specifications Test method transfer or method validation activities Development of sampling plans for OQ/PQ activities (includes Serialization and Sterilization activities) Supports the generation of documentation such as Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R & test requirements. Facilitating/Participating in FMEA Risk Assessments related to products and processes Statistical data analysis Trend manufacturing data and contract service providers results Development of validation/re-qualification protocols Assist in the development of Master Batch Records Act as technical resource for onboarding new equipment Technical resource in meetings/calls with customers Assist in root cause analysis of deviations/complaints Participate in Customer and Regulatory Audits as needed Knowledge of and adherence to all PCI, cGMP and GCP policies, procedures, and rules This position may require extra hours and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
Special Demands: Stationary Position: From 1/4 to 1/2 of the day. Move, Traverse: From 1/4 to 1/2 of the day. Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day. Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day. Ascend/Descend or Work Atop: Up to 1/4 of the day. Position self (to) or Move (about or to): Up to 1/4 of the day. Communicate or exchange information: 3/4 of the day and up. Detect, distinguish, or determine: 3/4 of the day and up.
On an average day, the individual can expect to move and/or transport up to 10 pounds
less than 1/4 of the day.
Required: Individual will possess a College Degree (engineering degree or related scientific degree) and must have a minimum of At least three years of experience in an FDA regulated industry. The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs. College Level Mathematical Skills Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs. Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
Preferred: Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines. Prior experience in technical writing and utilizing root cause analysis tools is required. Problem solving skills along with a strong collaborative approach is required. Lean Six Sigma or other formal process improvement skillsets are required Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.
Equal Opportunity Employer/Vet/Disabled