The Role
Lead quality activities for new product introductions and transfers, ensuring compliance with FDA and ISO standards. Review and approve design control deliverables, lead risk management (FMEA, hazard analyses), support process validation (IQ/OQ/PQ, MSA, software validation), qualify suppliers, resolve development and launch quality issues, participate in audits/inspections, and mentor engineering staff.
Summary Generated by Built In
- Provide quality leadership and guidance throughout new product development, technology transfers, and product launch activities.
- Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and other applicable regulatory requirements.
- Participate as the Quality representative on cross-functional NPI and product development teams.
- Review and approve Design Control deliverables, including design plans, user requirements, specifications, verification and validation protocols, and design transfer documentation.
- Lead and facilitate risk management activities, including risk assessments, FMEA development, hazard analyses, and risk-control verification.
- Support manufacturing process development and validation activities, including IQ, OQ, PQ, MSA, and software validation where applicable.
- Collaborate with Manufacturing Engineering to ensure robust process controls and production readiness prior to product launch.
- Partner with Supplier Quality and Procurement teams to qualify and monitor suppliers supporting new product introductions.
- Review and approve validation protocols, engineering studies, and technical reports.
- Drive resolution of quality issues identified during development, validation, pilot builds, and commercialization phases.
- Support design transfer activities to manufacturing sites.
- Ensure appropriate quality metrics, inspections, and acceptance criteria are established for new products and processes.
- Support site continuous improvement projects as needed.
- Participate in internal and external audits and support regulatory inspections as required.
- Mentor and supervise engineers and provide technical leadership on quality and compliance-related initiatives.
Skills Required
- Provide quality leadership for NPI and product launches
- Knowledge of FDA QSR (21 CFR Part 820)
- Knowledge of ISO 13485
- Knowledge of ISO 14971
- Experience with Design Controls (design plans, URS, V&V, design transfer)
- Experience leading risk management activities (FMEA, hazard analyses, risk-control verification)
- Support manufacturing process development and validation including IQ/OQ/PQ and MSA
- Experience with software validation where applicable
- Collaborate with Manufacturing Engineering to ensure process controls and production readiness
- Partner with Supplier Quality and Procurement to qualify and monitor suppliers
- Review and approve validation protocols, engineering studies, and technical reports
- Participate in internal and external audits and support regulatory inspections
- Mentor and supervise engineers; provide technical leadership on quality initiatives
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The Company
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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