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Company

PENTAX Medical · 8 hours ago

Senior Quality Engineer

Montvale, NJ

Full-time

Remote

Mid, Senior Level

3+ years exp

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Responsibilities

Lead the Quality Planning process ensuring identification, establishment, and monitoring of parameters utilized for ensuring a sustainable Quality Management System

Provide oversight on the Non-conformance system and manage the Material Review Board process

Support design verification and validation test plans, protocols, procedures and reports; actively participate in cross functional formal design reviews and design transfer

Support risk management activities conducted by Engineering, ensure that analyses track to requirements

Execute Supplier Quality Process

Coordinate the preparation of the Quality System Management Review

Function as SME for Statistical Techniques methods and application

Facilitate the monitoring of the Quality System’s effectiveness by leading the Internal Audit Process

Ensure execution of the Internal Audit Process by engaging the cross functional Internal Audit Team

Create, revise and review SOPs as applicable

Manage Quality Projects to timely and effective completion

Escalate opportunities for Corrective and Preventive action, assist with investigation/resolution, and confirm effectiveness when required

Monitor and facilitate the timely completion of all quality planning activities

Facilitate periodic meetings with function/product owners

Maintain thorough, well documented records of all process/product monitoring activities

Develop strong working relationships with domestic and global partners to ensure consistent, effective quality planning process and statistical techniques practices

Interact with regulatory bodies during inspections/audits

Support Field Action and Recall activities

Qualification

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Quality Management SystemStatistical TechniquesProject ManagementFDA regulationsISO standardsSix Sigma certificationASQ Certified Quality EngineerISO 13485 Lead AuditorTechnical Writing

Required

Bachelor’s degree in Engineering, Life Sciences or a related field

Minimum of 3-7 years’ Quality System experience in an FDA and/or ISO regulated environment

Thorough understanding of process/product monitoring methodologies

Demonstrated Project Management experience

Familiar with 21 CFR 820, ISO 14971 and 60601; ISO 13485 and the EU MDD and other domestic and international regulatory standards (i.e. GMP, FDA QSR, ISO, and MDD) in product requirements, design controls, software validation, V&V and operation

Strong ability to manage critical projects as part of an interdisciplinary team

Excellent problem solving, technical writing, and communication skills

Must be self-motivated and detailed oriented