Ensure product and process quality during manufacturing transfers (NPI, site transfers, supplier transfers) and throughout the sustaining phase by implementing, maintaining, and continuously improving quality systems, change management, risk management, and problem-solving activities, in compliance with applicable regulations and customer requirements.
Key ResponsibilitiesManufacturing TransfersActively participate in manufacturing transfer projects (NPI, inter-site transfers, supplier transfers).
Ensure quality requirements are properly defined, transferred, and validated.
Review and approve transfer-related documentation such as PFMEA, Control Plans, IQ/OQ/PQ, SOPs, BOMs, and process flows.
Coordinate quality activities with cross-functional teams (Engineering, Operations, Supply Chain).
Identify and mitigate quality risks associated with process, site, or supplier changes.
Support internal, customer, and regulatory audits related to transfers.
Provide ongoing quality support to manufacturing lines to ensure compliance with product specifications and quality KPIs.
Lead or support nonconformance investigations, CAPAs, and root cause analyses (8D, DMAIC, 5 Whys).
Evaluate and approve Engineering Change Requests/Orders (ECR/ECO/ECN).
Analyze quality trends (scrap, rework, complaints, yield) and drive continuous improvement actions.
Ensure proper maintenance and continuous improvement of quality system documentation.
Support supplier quality activities (SCAR, PPAP, incoming inspection controls).
Bachelor’s degree in Engineering (Industrial, Mechanical, Manufacturing, Biomedical, Electronic, or related discipline).
3–5 years of experience in Quality Engineering or related roles.
Demonstrated experience in manufacturing transfers and sustaining support.
Experience working in regulated industries (ISO 9001, ISO 13485, IATF 16949 preferred).
Quality tools: PFMEA, Control Plans, SPC, MSA, PPAP.
Strong root cause analysis and problem-solving skills.
Change management and document control.
Process validation (IQ/OQ/PQ).
Internal and external audits.
Quality metrics and KPI management.
Intermediate to advanced English (technical reading, writing, and communication).
Analytical thinking and structured problem-solving.
Ability to manage multiple priorities and projects.
Effective communication with cross-functional teams.
Strong attention to detail and regulatory compliance mindset.
Continuous improvement orientation.
Ability to work independently and escalate risks appropriately.
Timely and effective CAPA closure.
Post-transfer quality performance.
Reduction in defects, scrap, and rework.
On-time completion of transfer and NPI milestones.
Audit performance and compliance results.
Skills Required
- Bachelor's degree in Engineering (Industrial, Mechanical, Manufacturing, Biomedical, Electronic, or related)
- 3-5 years of experience in Quality Engineering or related roles
- Demonstrated experience in manufacturing transfers and sustaining support
- Experience in regulated industries (ISO 9001, ISO 13485, IATF 16949)
- Knowledge and use of PFMEA and Control Plans
- Statistical Process Control (SPC) and Measurement System Analysis (MSA)
- PPAP and supplier quality processes (SCAR, incoming inspection controls)
- Process validation experience (IQ/OQ/PQ)
- Change management, document control, and evaluation/approval of ECR/ECO/ECN
- Root cause analysis and problem solving (8D, DMAIC, 5 Whys) and CAPA management
- Support and participation in internal, customer, and regulatory audits
- Quality metrics and KPI analysis (scrap, rework, yield, complaints) and continuous improvement
- Intermediate to advanced English (technical reading, writing, communication)
- Analytical thinking, ability to manage multiple priorities, effective cross-functional communication
- Strong attention to detail, regulatory compliance mindset, and ability to work independently/escalate risks
What We Do
ATL Technology is a full-service, vertically integrated engineering and manufacturing partner to the world's leading medical device OEMs. Founded in 1993 and based in Springville, Utah, the company specializes in the design and manufacture of advanced medical device solutions, including custom interconnect solutions and components for minimally invasive procedures and patient monitoring systems.
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