Quality Assurance Specialist

Position Overview:

Administer and perform the tasks associated with different quality processes in compliance with all applicable laws/regulations. Assist in carrying out tasks for changes in the Quality Management System (QMS) and coordinate implementation of new or revised quality processes, procedures, work instructions, and standards as applicable.

ESSENTIAL DUTIES:

• Process customer complaints, returns, and repair records. This includes:
  • Performing daily reviews of complaint, service, and repair cases to determine the need for Medical Device Reporting per 21 CFR 803.
  • Maintaining the complaint database.
  • Work with the Customer Service Representatives and repair technicians to communicate updates and satisfy customer needs.
  • Work with the Sourcing Representative on supplier-related incidents.
  • Tracking and updating statuses of all open complaints for trending and management review purposes.
  • Ensure case records are completed in full and cases closed without undue delay.
  • Readiness to pull completed records and present case details during external and internal audits.
• Act as the Document Control System Administrator. This includes:
  • Ensuring adequate review, approvals, and training for all document changes.
  • Ensuring the latest documentation is distributed to appropriate users,
  • Ensuring obsolete documentation is removed from distribution, and all related documents are filed appropriately.
  • Tracking and updating statuses of all document changes for trending and management review purposes.
• Perform Quality Assurance activities in support of designated quality processes such as:
  • Record retention
  • Training coordination
  • Customer support
  • Labeling and traceability
  • License verification
  • Supplier management
  • Inspection and final release
  • Calibration and Maintenance
  • Corrective and Preventive action
  • Control of NC Product
  • Product identification and segregation
• Perform ad hoc reviews of records to ensure system compliance.
• Other quality activities as needed.

RELATED DUTIES:

• Participate in the preparation for Internal and External Audits.
• Support other department initiatives as directed by the Quality Supervisor.

MINIMUM QUALIFICATIONS:

Training and Experience

• At least two years of relevant quality/regulatory experience in Medical Device or Pharmaceutical Industry or equivalent combination of education and experience.
• High School or Associates degree in a related field.

Knowledge, Abilities and Skills

• Proficient in Microsoft Office Suite (Excel, Power Point, Word and Outlook)
• Strong attention to detail.
• Ability to work in a team environment as well as alone with little direction.

• Excellent verbal and written communication skills to all levels of the organization.
• Strong organizational skills required.

PHYSICAL REQUIREMENTS:

The position requires the ability to sit, stand, stoop, bend, and walk frequently during the shift. The position may require working extended hours or on weekends as needed. Incumbent may need to lift up to 30 lbs. on occasion.

Working Conditions

Office environment and occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.

Travel less than 5%.

Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.