Quality Assurance Specialist

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. in other Quality Assurance tasks as
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* Education & Experience:

** 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 Service Max and 123

Compliance 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.

Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever-changing landscape of the healthcare industry, we offer the latest integrated solutions including advanced multimodal imaging, vendor-neutral data management and groundbreaking remote diagnostic technology.

A globally-oriented business, Topcon is focused on developing solutions towards solving societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, access to healthcare and physician shortages. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and a high quality of life.
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