LivaNova · 3 weeks ago
Senior Quality Engineer
Colorado, United States
Full-time
Hybrid
Senior Level, Lead/Staff
$75K/yr - $125K/yr
8+ years exp
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Responsibilities
Manage product lifecycle ensuring compliance with design control and risk management procedures.
Serve as a core team member on product development teams and sustaining teams by providing technical expertise, direction and authoring deliverables.
Establish supplier qualifications and supplier process verification and validation.
Contribute to successful regulatory audits in back room/front room activities and serving as a subject matter expert.
Qualification
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Required
More than 5 years experience working on project teams resulting in PMA and 510k submissions.
Successfully demonstrates an in-depth or breadth of engineering skill(s). Technical education or experience in an area related to cardiopulmonary or perfusion devices.
Understands and can give examples of quality leadership, change management, implementation of change, acceptance sampling, statistical process control, risk management, design for manufacturing.
Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning.
Results oriented with capability to prioritize and plan activities with attention to understanding expectations of internal and external stakeholders.
Develop and maintain strong, positive business relationships with key internal customers such as R&D, Project Management Office (PMO), Clinical, Regulatory Affairs, Sales and Marketing, and Finance (as appropriate) to fulfill design development activities, support audits / inspections, and develop and implement quality plans that will ensure company compliance with regulatory requirements.
Open and honest with communication both up and down the leadership chain.
Project management skills including outlining activities to be done and setting timeframes and tracking to completion.
Proficient in all MS products, experience in MS Project or other planning tools.
Knowledge of regulatory requirements (e.g., FDA, ISO) as required for the position.
Strong written and spoken English.
Excellent communication and presentation skills.
Must be willing to take on related duties as required in support of company and departmental objectives.
Engineering degree.
Minimum related work experience of 8-10 years in Class II/III medical device manufacturing.
Preferred
Advanced engineering degree preferred.
ASQ Certified Quality Engineer or other ASQ Certifications is a plus.
Benefits
Health benefits – Medical, Dental, Vision
Personal and Vacation Time
Retirement & Savings Plan (401K)
Employee Stock Purchase Plan
Training & Education Assistance
Bonus Referral Program
Service Awards
Employee Recognition Program
Flexible Work Schedules
Company
LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment.
1001-5000 employees
H1B Sponsorship
LivaNova 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
2023 (4)
2022 (8)
2021 (9)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$300M2024-03-05Post Ipo Debt· $300M
2015-10-19IPO
Leadership Team
Vladimir Makatsaria
CEO
Alex Shvartsburg
CFO
Recent News
2024-12-18
2024-12-18
Company data provided by crunchbase
