Full-Time

Quality Assurance Engineer

Confirmed live in the last 24 hours

ZOLL Medical Corporation

ZOLL Medical Corporation

1,001-5,000 employees

Enterprise Software
Biotechnology
Healthcare

Junior, Mid

Lowell, MA, USA

Category
QA & Testing
Quality Assurance
Required Skills
SQL
Requirements
  • Requires a BS degree required or
  • Equivalent experience in a technical or scientific discipline required
  • Experience in an FDA regulated Class III electrical medical device manufacturing environment required
  • Experienced in process development and validation for electro-mechanical assembly, test, and service required
  • Formal Project management experience a plus preferred
  • Lean experience preferred
  • Experience with database queries and reporting in SQL or Microsoft Access preferred
  • Six Sigma Green Belt Certification Preferred
  • Black Belt Preferred
Responsibilities
  • Performs internal quality audits and effectiveness reviews (FDA’s QSR, ISO 13485, MDD, CMDR). Conducts supplier evaluations and audits.
  • Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality.
  • Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance.
  • Responsible to build and improve key business relationships within the organization’s cross functional departments.
  • Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications.
  • Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented.
  • Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
  • Prepare, submit and coordinate the process validation requirements for non-product software validations.
  • Participates in the FDA premarket approval process (PMA) for new and modified medical devices.
  • Participates in the nonconforming material/Material Review Board process. Championing the implementation of Lean Manufacturing processes.
  • Participate in Kaizen events as a representative of the quality department.
ZOLL Medical Corporation

ZOLL Medical Corporation

View

Company Stage

Acquired

Total Funding

N/A

Headquarters

null, null

Founded

1980

Simplify Jobs

Simplify's Take

What believers are saying

  • Increased demand for remote monitoring boosts ZOLL's product line potential.
  • AI-driven analytics interest enhances ZOLL's software for patient monitoring.
  • Wearable medical devices market expansion offers innovation opportunities for ZOLL.

What critics are saying

  • Ransomware attack litigation could impact ZOLL's reputation and finances.
  • Evolving EU MDR compliance may increase operational costs for ZOLL.
  • Intense competition requires ZOLL to continuously innovate, straining resources.

What makes ZOLL Medical Corporation unique

  • ZOLL's AR Boost is ranked #1 in 2024 Insurance Discovery Solutions.
  • ZOLL AED 3 defibrillator is EU MDR certified, ensuring high safety standards.
  • Therox Supersaturated Oxygen Therapy received an Innovative Technology contract from Vizient.

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