• Job Description

  Req#: JR106915
  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 leads and provides support to investigations involving Complaints, 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 enjoys cross functional collaborations. Your work will directly contribute to compliance, continuous improvement, and operational excellence in the company.
  
  Responsibilities:
  
  
  • Analyze and investigate 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 Quality Assurance Management.
  
  
  
  • Issue Supplier Corrective Action Requests and work closely with suppliers and internal teams on their resolutions.
  
  
  
  • Coordinate Supplier Qualification process by assessing 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.
  
  
  
  • Assist in internal and Regulatory audits as required.
  
  
  
  • Assist in other Quality Assurance tasks as required.
  
  
  Education & Experience:
  
  
  • Bachelor or higher degree in science or related field
  
  
  
  • 2+ years experience in a regulated manufacturing environment (medical devices, aerospace, communications, automotive, etc.)
  
  
  Knowledge, Skills, and Abilities:
  
  
  • Familiarity with FDA QSR and ISO Requirements
  
  
  
  • Familiarity with ServiceMax and 123Compliance a plus
  
  
  
  • Detail-oriented with good analytical ability and problem-solving skills.
  
  
  
  • Ability to work independently and efficiently and work well with others.
  
  
  
  • Good organizational and communication skills (verbal and written)
  
  
  
  • Ability to follow detailed written procedures; handle multiple tasks simultaneously and prioritize accordingly.
  
  
  Base Pay:
  
  Expected Base Pay Range: $60,000 to $80,000 Annualized
  
  The base pay range included is a projected hiring range for a position, level and potential work location(s) listed. Topcon provides the compensation range that it in good faith believes it might pay and/or offer for this position. This compensation range is based on a full-time schedule.
  
  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.
  
  Topcon reserves the right to ultimately pay more or less than the posted range and offer additional benefits and other compensation; individual candidate compensation may be determined based on individual skills, experience, training, certifications, education, final work location and other factors not related to an applicant's sex or other status protected by local, state, or federal law. Changes in the position level, location or other factors associated with the role may change the final determined compensation. The recruiter can provide additional information during the hiring process.
  
  *Topcon time off policies can vary between roles which are exempt or non-exempt. For hourly ("non-exempt") employees, we offer personal paid time off which accrues in accordance with local standards. For salaried ("exempt") employees, we offer a flexible paid time off policy giving you flexibility to take time when needed, while supporting business needs. All paid time off policies are in accordance with or exceeding local law. Employees working at least 30 hours per week are eligible for our Health and Welfare benefit package.
  
  EEO Statement:
  
  We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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