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Company

Original Job Post

Alphatec Spine · 2 days ago

Manager, Quality Engineering

Carlsbad, CA

Full-time

Onsite

Senior Level

$125K/yr - $135K/yr

7+ years exp

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Responsibilities

Hire and retain highly qualified staff and provide coaching, mentoring, career development and ongoing performance feedback

Assign and review project work of staff, set work and resourcing priorities, and review/course correct the output of project deliverables

Implement data collection system for relevant metrics integrated within ATEC Quality Objectives.

Implement forum for ongoing technical training related to Validation Engineering skills & techniques to match needs of the business.

Manage the team responsible for verification and validation activities for new product development & sustaining engineering projects

Provides individual Verification and Validation Engineering expertise for Design Controls to ensure efficient, effective, and compliant new product launches including requirements evaluation, end-to-end traceability and the establishment of V&V Plans

Manual and automated system test method development and qualification

Represent Validation Engineering when collaborating with designated personnel to develop various Computer Systems Validation (CSV) documents per FDA guidance (General Principles of Software Validation), including but not limited to Requirements Specifications, Validation/Test Plan, Testing, Integration Test Scripts, Operational/System Test Scripts, Validation Summary Reports

Influence Risk Management efforts in accordance with ISO 14971 and IEC 62304

Maintain regular and consistent attendance at the normal worksite

Other duties as assigned.

Qualification

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FDA Quality System RegulationsISO 13485 2016IEC 62304IEC 60601ANSI C63 27ISO 14971ALM softwareRequirement elicitationTraceabilityTest method qualificationGage R&RAttribute Agreement AnalysisBiocompatibility requirementsSPCDOEProbabilityStatisticsTestingValidation of medical productsWriting protocolsWriting reportsWriting proceduresProject management techniquesTechnical expertiseExecutive management communicationMeasuring project resultsRisk mitigation discussionsCross-functional team managementProject managementRegulated industry experience

Required

Firm understanding of the FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016)

Extensive knowledge of IEC 62304, IEC 60601 requirements

Knowledgeable with ANSI C63:27 American National Standard for Evaluation of Wireless Coexistence requirements

Proficient knowledge of ISO 14971 requirements

Proficient knowledge with Requirement & Test Case management utilizing ALM software

Proficient knowledge with requirement elicitation, traceability, and verification

Proficient knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) including competency using desktop lab equipment (function generators, oscilloscopes, etc)

Proficient knowledge of biocompatibility requirements, SPC, DOE, probability and statistics

Extensive demonstration of successful testing and validation of medical products through full life cycle including writing protocols, reports, and procedures required

Strong ability to demonstrate comprehensive knowledge of project management techniques to ensure predictability of complex cross-functional projects

Strong ability to demonstrate technical expertise and communicate with internal and external customers and executive management

Must be deadline-oriented and detail-oriented, an effective communicator, and able to work within a team environment

Ability to measure project results (impact to business) using appropriate systems, tools, and techniques

Work within a defined system to publish milestones, track progress, and facilitate risk mitigation discussions

Ability to work independently as a project manager and manage a working cross-functional team

Self-starter, works independently and maintains positive, enthusiastic attitude with a high-level of attention to detail/quality

Ability to handle competing priorities and a broad variety of tasks simultaneously under high pressure and ambiguity

Excellent oral and written communications skills with the ability to interface and influence at all organizational levels

Strong facilitation skills, confident communicator (both verbally and written) with all levels of an organization and diverse audiences

Ability to develop and maintain strong working relationships with internal and external customers and suppliers

Bachelor's degree from four-year College or university in Engineering, or equivalent experience

Minimum of 7 years of experience in a regulated industry in disciplines of Quality Engineering, Systems Engineering. Medical device experience preferred

Preferred

ASQ CSQE/CQE preferred

ASQ CMQOE preferred

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable)

Company

Alphatec Spine

Alphatec Spine is a medical device company developing products and treatments for spine disorders.

Founded in 1990

Carlsbad, California, USA

501-1,000 employees

https://atecspine.com

H1B Sponsorship

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