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Senior Quality Associate

Hoveround Corporation
3.3 out of 5
2151 Whitfield Industrial Way, Sarasota, FL 34243
Full-time

Location

2151 Whitfield Industrial Way, Sarasota, FL 34243

Benefits
Pulled from the full job description

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Disability insurance
  • Employee assistance program
  • Employee discount
  • Flexible spending account

Full job description

Senior Quality Associate

In this role, you will serve as the Quality Management Representative for the company. This includes responsibility for oversight of the quality inspectors, internal audits, maintenance of quality records and administration of the document control system. You'll assist with investigations and reporting of Medical Device Complaint’s and Customer complaints. In addition, you will work with Engineering on product enhancements and change control. This role is responsible for controlling the draft and release, storage, tracking and distribution of documents. This position reports to the Vice President of Operations.
MANUFACTURING SUPPORT:

  • Provides support to the Vice President of Operations.
  • Serves as Quality Management Representative for the organization.
  • Responsible for oversight of the quality inspectors, internal audits, maintenance of quality records and administration of the document control system .
  • Assists with investigation and reporting of MDC’s and Customer complaints.
  • Works with Engineering on product enhancements and change control.
  • Works with Manufacturing on identifying, recommending and implementing process improvements.
  • Researches, analyzes and compiles data for monthly Key Performance Indicators (KPI’s).
  • Provides support to Field, Manufacturing, Quality Assurance and Materials departments as needed.
  • Handles a variety of executive, sensitive and confidential information.*

DOCUMENT CONTROL:

  • Organization of the document control system.
  • Routing and tracking of documents for approval.
  • Release of documents and distribution of copies.
  • Ensure current document revisions are available on company intranet.
  • Preservation of document masters.
  • Document master list maintenance.
  • Member of internal audit team.
  • Perform assigned internal audits and prepare reports.

The right candidate will have the following:

  • Experience with Quality Management Systems in a manufacturing environment.
  • Five (5) or more years of Quality experience in medical device manufacturing
  • Demonstrated ability to prepare for, manage and successfully under FDA Inspections.
  • Proficiency in a Windows environment, emphasizing Word, Excel and PowerPoint.
  • Excellent written and verbal communication skills.
  • Strong organizational and time management skills.
  • Ability to maintain confidentiality when exposed to sensitive company information.

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Disability insurance
  • Employee assistance program
  • Employee discount
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off
  • Referral program
  • Retirement plan
  • Vision insurance

Schedule:

  • 8 hour shift

Ability to Commute/Relocate:

  • Sarasota, FL 34243 (Required)

Experience:

  • FDA regulations: 2 years (Preferred)
  • Quality Control: 5 years (Preferred)
  • Quality Management Systems: 3 years (Preferred)

Work Remotely:

  • No