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Quality Engineer jobs in United States
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GCX · 17 hours ago

Quality Engineer

GCX Healthcare Solutions is focused on quality engineering in the development and maintenance of products and processes. The Quality Engineer will utilize quality engineering tools and practices to improve product quality and efficiency throughout the product lifecycle, while supporting quality improvement initiatives and compliance activities.
HealthcareHealth Care
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Senior Management
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H1B Sponsor Likelynote

Responsibilities

Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements
Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs
Conduct benchmarking to develop more effective methods for improving quality
Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management
Supports activities related to the Material Review Board
Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate
Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing
Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support
Develop, interpret, and implement standard and non-standard sampling plans
Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis

Qualification

Quality EngineeringNPI/Design ControlsGMP/ISO regulationsCQE certificationLSSGB certificationProject ManagementAnalytical skillsProblem-solving skillsCommunication skillsOrganizational skillsAttention to detail

Required

Bachelor's degree (B.S.) in an Engineering, Technical, or Scientific field
Minimum of 6 years of relevant experience, or advanced degree with minimum of 4 years relevant experience
Commitment to excellence and high standards
Strong organizational, problem-solving, and analytical skills
Ability to manage priorities and workflow
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
Acute attention to detail
Demonstrated ability to plan and organize projects
Ability to work independently and as a member of various teams
Proven ability to manage multiple projects and meet deadlines
Ability to develop clear, concise, and timely oral and written reports
Accurately complete detailed forms and reports

Preferred

Understanding of the NPI (New Product Introduction)/Design Controls process and Process Validation expertise
A thorough understanding of GMP/ISO regulations and validation regulations
Prior experience working in medical device industry
CQE or LSSGB certification
Project Management skills
Excellent written and oral communication skills

Company

GCX

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By dedicating ourselves specifically to the healthcare industry, we have been able to develop a unique understanding of the interaction between medical devices, users, and healthcare environments.

H1B Sponsorship

GCX 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 (1)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2021-09-20Acquired

Leadership Team

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John Kruger
President, CEO
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Michael Picchi
Chief Financial Officer
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Recent News

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