Quality Assurance Specialist

Position Overview:

The quality assurance specialist assists in ensuring that medical devices meet established quality standards and regulatory requirements. This role involves supporting quality assurance activities, documentation processes, and compliance efforts under the guidance of senior quality assurance personnel.

Responsibilities:

• Support and comply with the company’s Quality Management System policies and procedures.
• Review records for GMP compliance and consistency with company policies and procedures necessary to support customers’ quality requirements.
• Exercise excellent oral and written communication skills; strong attention to detail and record-keeping skills.
• Perform document control processes ensuring files are accurate and easily retrievable. Serve as a point of contact for document-related inquiries and support
• Performing incoming material inspections and releases.
• Coordinates with the manufacturing department to perform line clearances and in-process verifications as needed.
• Issues and manages documents for the manufacturing department.
• Route documents for review and approval in the Document Management System.
• Approves Document Change Controls and assigns effective dates to documents.
• Route training records to employees and maintain an internal training log.
• Aids QA lead and management during internal audits and support external audits and regulatory inspections.
• Creates and maintains databases for quality assurance and document control as needed.
• Participates in the implementation of eQMS.
• Maintain and improve processes to monitor document workflow performance, compliance, and reliability.
• Participates in investigations for quality events such as NCR, Deviations, and CAPA.
• Participates in training and development activities to advance core competencies and quality knowledge.
• Partner with other team members for the records management program.
• Assist with the development of document templates for various document types.
• Perform general word processing for various procedures and other document types.
• Participates in additional projects as assigned by management.
  

Qualifications:

• Bachelor’s degree in science or related field.
• Minimum of 1-2 years of experience with Quality Assurance in the medical device, biotech or related industry. Working knowledge of ISO 13485 is preferred.
• Excellent communication and interpersonal skills.
• Strong problem-solving abilities and attention to detail.
• Ability to work in a fast-paced and dynamic environment.

 Benefits:

• 
  Competitive Salary
• 
  PTO /Sick time
• 
  Paid Holidays
• 
  401(K)
• 
  Medical, Dental and Vision insurance
• 
  Life Insurance with the option of Voluntary Life Insurance (Buy-Up)
  
• 
  Employee Assistance Program

Salary : $56,000 - $70,000