QA Specialist

SUMMARY:

Quality Assurance Specialist will provide support and maintain core quality systems for compliance with applicable regulations. Must be highly organized, detail-oriented, and eager to learn. Work closely with other departments to maintain a high level of compliance in all regulated activities.

Excellent written and verbal presentation and communications skills required. Demonstrates ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.

Responsibilities:

· Issue, log and review customer complaints while maintaining the accuracy of the documentation from the initial receipt of a product complaint to its closure in the complaint file.

· Collaborate with internal teams (Customer Support, Sales, Regulatory, Engineering, etc.) to gather additional information when needed.

· Assist in maintaining the complaint log and ensuring records are accurate and complete.

· Inspection and testing of products and components to ensure that the products comply with the relevant specification and design requirements.

· Continuous improvement of QA receiving inspection process and procedures.

· Analyze failures, corrective, and preventive actions to respond to customer complaints.

· Manage suppliers' performance and conduct supplier audits.

· Conduct internal audits, including resolution of corrective action requests.

· Assist QA to create and maintain quality procedures and work instructions.

· Report problems or concerns to senior management immediately.

· Trend data and prepare QA reports, as needed

· Assist with special projects and other duties as required.

· Other needed duties may be assigned at the discretion of QA/RA Management.

Qualification/Experience:

· High School Diploma is required

· 1-2 years of experience in Medical Device industry or equivalent,

· Complaint handling experience is preferred

· Internal auditing experience is preferred.

· ISO 13485 certification is preferred.

· Skills with Microsoft Office Suite (Word, Excel, Power Point) is preferred

· Basic computer skills are required

· Analytical, logical thought process and meticulous attention to detail

· Positive, results-oriented, and energetic team player

· Ability to translate skills and knowledge to others

· Excellent written and oral communication skills

Job Type: Full-time

Pay: $60,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person