Associate Quality Engineer - Design jobs in United States
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Zimmer Biomet · 7 hours ago

Associate Quality Engineer - Design

Zimmer Biomet is a global medical technology leader committed to enhancing patient mobility. They are seeking an Associate Quality Engineer - Design to support their R&D team by developing and maintaining quality systems throughout product development, manufacturing, and supply chain operations.

Health CareManufacturingMedical DeviceProduct Design
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H1B Sponsor Likelynote

Responsibilities

Participate on project teams as a contributing member by providing quality engineering support under the direction of Sr. Design Quality Engineers & management in the development of new products and processes, supporting legacy released systems, and continuously improving company’s products
Provide support for the manufacturing areas (internal and external). Work with production personnel and supervision to determine and monitor quality metrics, sample plans, and inspection methods
Participate in the non-conforming product process to address and resolve issues. Support corrective and preventive action investigations to resolve the root cause of problems
Perform inspections and use typical equipment used in inspection
Assist project teams on compliance with design control requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards
Participate in risk management activities in compliance with ISO 14971 as expressed in the company’s Quality Management System
Assist in supplier qualification process; interface with suppliers to ensure product compliance to specification
Support the execution of verification & validation protocols, testing, and generation of test reports
Assist in Design Control and Transfer for release of new product development projects
Support the writing and reviewing of procedures, plans, protocols, and reports to ensure regulatory compliance
Accurately represent quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.)
Other duties as assigned

Qualification

Quality Management SystemsISO 13485 2016FDA QSR complianceGeometric DimensioningTolerancingMachining methodologiesTechnical writingComputer skillsMedical Device Design Controls

Required

Bachelor's in engineering or technical discipline
Familiarity with 21 CFR 820 and ISO 13485:2016 and other Government / ISO Standards
Technical writing skills that include Quality Management Systems (QMS) and procedures
Knowledge in Geometric Dimensioning and Tolerancing (GD&T)

Preferred

Familiarity with Medical Device Design Controls
Knowledge in Machining methodologies preferrable (Titanium and Stainless-Steel experience best), knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with Suppliers and Engineers
Competent computer skills (MS Office Suite, SAP Preferred)

Benefits

Development opportunities
Robust employee resource groups (ERGs)
A flexible working environment
Location specific competitive total rewards
Wellness incentives
A culture of recognition and performance awards

Company

Zimmer Biomet

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Zimmer Biomet is a medical device manufacturing company that offers orthopedic reconstructive, spinal, and trauma devices.

H1B Sponsorship

Zimmer Biomet has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.75B
2025-02-20Post Ipo Debt· $1.75B
2016-12-14Post Ipo Debt· $1B
2001-08-03IPO

Leadership Team

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Ivan Tornos
Chairman, President and CEO
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David DeMartino
Senior Vice President, Investor Relations
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Company data provided by crunchbase