US_East | Manufacturing & Process Engineer_L2

Job Description

Job Description

Role Name: Junior Quality Engineer
Work Location: Pittsburgh, PA – Onsite

• Support Design Quality activities throughout new product development, including design reviews, requirements reviews, risk management, verification and validation planning, and design transfer readiness.
• Support Design Transfer activities by ensuring product and process requirements are properly translated into manufacturing, inspection, supplier, validation, and release deliverables.
• Lead and participate in Design Failure Mode and Effects Analysis (DFMEA) and other risk assessment activities.
• Participate in DFMEA, PFMEA, process flow, control plan, and risk assessment activities to ensure design and manufacturing risks are identified, mitigated, and appropriately documented.
• Review verification and validation protocols and participate in V&V planning to ensure alignment with product requirements.
• Review verification, validation, inspection, equipment qualification, and process validation protocols to ensure alignment with product requirements, risk controls, and design transfer needs.
• Support testing strategies and robust verification and validation processes.
• Support execution and documentation of equipment qualification and process validation activities, including IQ/OQ/PQ, validation reports, and related production-readiness evidence.
• Support Design Control activities and ensure compliance with applicable FDA and international regulatory requirements.
• Support supplier and process readiness activities, including review of supplier documentation, inspection results, capability studies, MSA/Gage R&R, and supplier approval packages.
• Develop and execute supplier qualification activities, including supplier agreements/contracts and Production Part Approval Process (PPAP) documentation.
• Develop inspection techniques and procedures to ensure product integrity and conformance to design specifications.
• Write, review, approve, and implement incoming, in-process, final inspection, and operator self-inspection procedures.
• Work with Quality Engineers and Metrology Laboratory personnel to develop product gauging and measurement methods.
• Collaborate with suppliers, management, Engineering, and Manufacturing teams to investigate and resolve quality-related issues.
• Assist with capability studies and application of statistical quality control methodologies.
• Partner with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies.
• Recommend process-monitoring devices and controls where applicable.
• Assist with product complaint investigations and associated documentation.
• Interface with Regulatory Affairs to support UL, IEC, FDA, and other applicable regulatory submissions.
• Participate in internal audits and audits conducted by regulatory agencies.
• Manage and drive timely resolution of nonconformances and Corrective and Preventive Actions (CAPAs).

• Bachelor’s degree in Engineering, Quality, or a related technical field required; Master’s degree preferred.
• 3+ years of experience in Medical Device Quality Engineering or a related field.
• Strong knowledge of ISO 13485, FDA Quality System Regulation requirements, EU MDR, and ISO 14971 risk management principles.
• Experience with Design Controls, Process Validation, CAPA, and Supplier Quality.
• Experience with equipment qualification and process validation activities, including IQ/OQ/PQ.
• Knowledge of DFMEA, PFMEA, control plans, capability studies, MSA, and Gage R&R.
• Proficiency with statistical analysis tools such as Minitab and related quality-analysis tools.
• Strong knowledge of structured problem-solving methodologies such as 8D and DMAIC.
• Certified Quality Engineer (CQE) and/or Six Sigma certification is a plus.