Quality Assurance Specialist

Topcon Healthcare • Oakland, NJ

22h • $60,000 - $80,000

About The Position

For over 90 years, Topcon’s vision has been to solve societal challenges around the globe. In healthcare, we are developing innovations that improve patients’ health and quality of life. We empower eye care providers with advanced imaging, diagnostic solutions, and intelligent data technology. Our robotic devices deliver simplicity without compromise, by capturing clear images with the push of a button. By joining Topcon Healthcare, you become part of a growing, diverse, global team. With office locations throughout North America, whether you are on-site, remote, or hybrid, our culture empowers you to contribute to company and personal success each day. At Topcon Healthcare, you can grow your career, gain new perspectives, and help address society’s most pressing challenges. If you have drive, passion, and a desire to be part of a collaborative team, we want to hear from you. At Topcon Healthcare, we don’t wait for the future. We invent it. Join us. Learn more about working with us at topconcareers.com The Quality Assurance Specialist lea ds and provid es support to investigations involving Complaint s , Corrective and Preventive Actions ( CAPA ) , and nonconformance to ensure our processes meet regulatory and Quality Management System requirements. We are looking for an individual who is detailed-oriented with effective communication and strong analytical skills who enjoy s cross functional collaborations. Your work will directly contribute to compliance, continuous improvement, and operational excellence in the company.

Requirements

• Bachelor or higher degree in science or related field
• 2 + years experience in a regulated manufacturing environment (medical devices, aerospace, communications, automotive, etc. )
• Familiarity with FDA QSR and ISO Requirements
• Detail -o riented with good analytical ability and problem-solving skills.
• Ability to work independently and efficiently and work well with others.
• G ood organizational and communication skills (verbal and written)
• Ability to follow detailed written procedures; handle multiple tasks simultaneously and prioritize accordingly.

Nice To Haves

• Familiarity with ServiceMax and 123Compliance a plus

Responsibilities

• A nalyz e and investiga te reported quality issues in accordance with company guidelines and external regulatory requirements.
• Maintain and analyze problem logs to identify and report trending or recurring issues to Q uality A ssurance M anagement .
• Issue Supplier Corrective Action Requests and work closely with suppliers and internal teams on their resolutions.
• Coordinate Supplier Qualification process by assess ing supplier risk and maintain supplier questionnaire, agreement , and other related documentation.
• Assist in updating company Quality Management System procedures to ensure proper process workflow and documentation.
• Work closely with internal departments for resolution of complaints and any CAPA resulting from quality issues .
• A ssist in internal and Regulatory audits as .
• A ssist in other Quality Assurance tasks as .

Benefits

• Topcon offers a comprehensive benefit package for this position including medical, dental, vision, life insurance, disability insurance, tax saving spending accounts a 401(k) plan with employer match, tuition reimbursement in addition to other perks and benefits.
• We also offer time off for our employees to recharge.
• Our employees are eligible for paid company holidays, paid personal time off, and paid sick time that meets or exceeds state/local requirements.
• Employees working at least 30 hours per week are eligible for our Health and Welfare benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level