DS
US_East | Manufacturing & Process Engineer_L2
Datum Software, Inc
🇮🇱 Israel
On-site
Junior
1 month ago
- Risk Management
- PFMEA
- IEC
- CAPA
- Minitab
- Six Sigma
1 month ago
Work Location: Pittsburgh, PA – Onsite
Job Summary
The Junior Quality Engineer will support quality activities throughout the new product development lifecycle, with a focus on Design Quality, Design Controls, risk management, verification and validation, supplier quality, process validation, and manufacturing readiness. This role will collaborate closely with Engineering, Manufacturing, Suppliers, Regulatory Affairs, Metrology, and other Quality team members to ensure products and processes meet applicable regulatory, quality, and performance requirements.
Essential Duties and Responsibilities:
- 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).
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Education and Experience:
- 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.
Building Strategic Working Relationships
Develops and maintains collaborative relationships across functions to facilitate the successful accomplishment of organizational and project goals.
Quality Orientation
Completes tasks with attention to all relevant details, demonstrates concern for all aspects of quality, accurately reviews processes and deliverables, and consistently monitors work for compliance and accuracy.
Decision Making
Identifies and understands issues, problems, and opportunities; analyzes information from multiple sources; develops appropriate solutions; and takes action consistent with available facts, constraints, risks, and potential consequences.
Performance / Work Standards
Sets high standards of performance, demonstrates accountability, and takes responsibility for successfully completing assigned tasks and deliverables while maintaining flawless execution of fundamental processes.
Information Monitoring
Establishes and maintains effective processes for collecting, reviewing, tracking, and communicating information required to manage ongoing activities and organizational objectives.
“All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.”
US_East | Manufacturing & Process Engineer_L2 · Datum Software, Inc